checkAd

    3$ für ein halleluja..... - 500 Beiträge pro Seite

    eröffnet am 05.06.06 17:11:58 von
    neuester Beitrag 06.12.06 18:43:05 von
    Beiträge: 38
    ID: 1.064.227
    Aufrufe heute: 0
    Gesamt: 2.069
    Aktive User: 0


     Durchsuchen

    Begriffe und/oder Benutzer

     

    Top-Postings

     Ja Nein
      Avatar
      schrieb am 05.06.06 17:11:58
      Beitrag Nr. 1 ()
      ;)
      Der Chart verspricht keine Langeweile - egal was kommt!



      Bin zu 3$ eingestiegen...
      nk
      Avatar
      schrieb am 05.06.06 17:16:54
      Beitrag Nr. 2 ()
      Antwort auf Beitrag Nr.: 21.953.913 von nkelchen am 05.06.06 17:11:58;)

      ach ja -
      no risk no fun...


      nk
      Avatar
      schrieb am 05.06.06 17:21:20
      Beitrag Nr. 3 ()
      Antwort auf Beitrag Nr.: 21.953.972 von nkelchen am 05.06.06 17:16:54:look:

      AP
      Dov Pharmaceutical Pain Drug Fails Trial
      Monday May 22, 6:01 pm ET
      Dov Pharmaceutical Back Pain Drug Bicifadine Fails Phase 3 Clinical Trial, Has Limited Results


      HACKENSACK, N.J. (AP) -- Dov Pharmaceutical Inc. provided more details Monday on a failed clinical trial of its lead drug candidate bicifadine, saying the treatment failed to show significant results in half the participants.
      ADVERTISEMENT


      Last month the company said the drug, aimed at treating chronic lower back pain, proved ineffective and that it would conduct a more detailed analysis of the phase 3 clinical trial results. It blamed the failure on a high placebo response rate.

      The analysis did show that as the severity of chronic low back pain worsened, the drug had a more significant effect. For example, patients with low back pain that radiated down the leg -- or sciatica -- were twice as responsive to treatment and patients with moderate to severe disability due to back pain had only one-third the placebo response of patients with mild to moderate disabilities. In all, the drug was effective on half the patients in the study.
      "While we are surprised and disappointed by the trial failure, we are encouraged by the effect of bicifadine in the two major subgroups," said Dr. Warrent Stern, senior vice president of drug development, in a statement.

      The company said it will continue its phase 3 trial, amending part of it by enrolling only patients who meet the subgroup criteria of severe pain or sciatica.

      Another part of the trial is already fully enrolled and will be used to provide the safety database necessary to file for approval.

      Also, the drug is in a phase 2 clinical trial, also to test its effectiveness, with the focus on osteoarthritis patients.

      Dov also said it will delay seven Phase 1 clinical trials necessary to file a new drug application with the Food and Drug Administration, saying they are short in duration and can be completed close to the filing date.

      Dov also will delay a manufacturing scale-up that would have been required if it was going to file a new drug application for bicifadine in the first half of 2007.

      The company added that it will cut $9 million out of the program budget as a result of restructuring the various clinical trials associated with bicifadine.

      Dov Pharmaceutical develops drugs to treat central nervous system and cardiovascular disorders. Shares of the company\'s stock fell 2.7 percent, or 8 cents, to close at $2.92 on the Nasdaq. They recently traded up 2 cents in aftermarket activity, according to Inet.
      Avatar
      schrieb am 05.06.06 17:58:49
      Beitrag Nr. 4 ()
      yep
      sieht vielversprechend aus

      zen ;)
      Avatar
      schrieb am 06.06.06 01:10:51
      Beitrag Nr. 5 ()
      Wo kommen die her ? "HACKENSACK, N.J. (AP)" ?!?!

      :laugh::laugh::laugh::laugh::laugh::laugh::laugh:

      die aktie wird elendig verenden ! :D

      Trading Spotlight

      Anzeige
      Nurexone Biologic
      0,4300EUR +4,62 %
      Die Aktie mit dem “Jesus-Vibe”!mehr zur Aktie »
      Avatar
      schrieb am 31.07.06 18:45:58
      Beitrag Nr. 6 ()
      Antwort auf Beitrag Nr.: 21.961.511 von bussibaer84 am 06.06.06 01:10:51:laugh:

      DOV Pharmaceutical Upgrade


      Rating-Update:
      New York (aktiencheck.de AG) - Die Analysten von Punk Ziegel & Co. stufen die Aktie von DOV Pharmaceutical (ISIN US2598581088/ WKN 541562) von "sell" auf "market perform" hoch. Das Kursziel werde bei 2,50 USD gesehen. (6.7.2006/ac/a/u)

      Analyse-Datum: 06.07.2006
      Avatar
      schrieb am 11.08.06 21:34:56
      Beitrag Nr. 7 ()
      Antwort auf Beitrag Nr.: 23.258.391 von coce am 31.07.06 18:45:58:D

      heute zu 0,90$ zu haben...
      Avatar
      schrieb am 18.08.06 06:38:27
      Beitrag Nr. 8 ()
      Ich bin gestern mit einer ersten Position eingestiegen und halte die MK von 24 Mio USD bei der aktuellen Pipline für viel zu niedrig.

      Kursziel ist für mich der Breich 2 - 2,5 USD.


      mfg
      Avatar
      schrieb am 18.08.06 13:44:35
      Beitrag Nr. 9 ()
      Bin seit Montag investiert und halte den Rest der Pipeline auch für einiges wertvoller als die aktuelle MK. Vielleicht haben wir ja Glück und es wird noch was mit dem Schlafmittel, dann sitzen wir auf einer richig guten Rakete:laugh:

      Gruß Cyberhai
      Avatar
      schrieb am 18.08.06 17:06:34
      Beitrag Nr. 10 ()
      Antwort auf Beitrag Nr.: 23.258.391 von coce am 31.07.06 18:45:58;)

      Chart sieht kurzfristig richtig gut aus.
      Könnte heute noch auf 1,30$ gehen, wenn wir das Hoch von Gestern breaken.
      Anschliessend sollte der Bereich um 1,90 angesteuert werden.
      Kann natürlich auch alles anders kommen..:cry:
      siehe Langfristchart!!
      Gruss
      Mn
      Avatar
      schrieb am 22.08.06 20:02:23
      Beitrag Nr. 11 ()
      Es dürfte bis zum 28. wohl noch runtergehen bis bekannt wird, dass DOVP aus der Nasdaq geflogen ist.
      Avatar
      schrieb am 31.08.06 18:07:48
      Beitrag Nr. 12 ()
      Antwort auf Beitrag Nr.: 23.565.197 von Extrabreit am 22.08.06 20:02:23:rolleyes:

      Habe heut noch ein paar zu 0,94 gekauft.
      Entweder wird das hier die Megarakete, oder eine Beerdigung 3.Klasse.
      Drum Totalverlust einplanen -
      viel Glück
      Mn
      Avatar
      schrieb am 31.08.06 18:17:28
      Beitrag Nr. 13 ()
      :rolleyes:

      DOV Pharmaceutical, Inc. Receives Staff Determination Letter from NASDAQ
      Company Intends to File a Hearing Request and Initiate the Appeals Process
      PrintE-mailDisable live quotesRSSDigg itDel.icio.usLast Update: 4:16 PM ET Aug 30, 2006


      SOMERSET, N.J., Aug 30, 2006 /PRNewswire-FirstCall via COMTEX/ -- DOV Pharmaceutical, Inc. (DOVP : dov pharmaceutical inc com
      News , chart, profile, more
      Last: 0.94-0.02-1.93%

      12:01pm 08/31/2006

      Delayed quote dataAdd to portfolio
      Analyst
      Create alertInsider
      Discuss
      Financials
      Sponsored by:
      DOVP0.94, -0.02, -1.9%) announced today that it has received a Staff Determination Letter from the NASDAQ Listing Qualifications Department indicating that the Company has not regained compliance in accordance with NASDAQ Marketplace Rule 4450(b)(1)(A) as the market value of DOV's common stock has remained below the minimum of $50,000,000 required for continued inclusion in The NASDAQ Global Market.
      DOV previously announced on July 31, 2006 that the NASDAQ Listing Qualifications Department notified the Company on July 28, 2006 that it failed to comply with the continued listing requirements of The NASDAQ Global Market because the market value of the Company's listed securities had fallen below $50,000,000 for 10 consecutive business days. Pursuant to NASDAQ Marketplace Rules, the Company was provided a period of 30 calendar days, or until August 28, 2006, to regain compliance.
      DOV intends to request a hearing before a NASDAQ Listing Qualifications Panel and will submit its plan of compliance in connection with such hearing. The hearing request will stay the staff's determination and, as a result, the Company's securities will remain listed on The NASDAQ Global Market until the Panel issues its decision following the hearing. The Company expects the hearing to be held in approximately 35 to 45 days. There can be no assurance that the Panel will grant the Company's request for continued listing on The NASDAQ Global Market.
      About DOV
      DOV is a biopharmaceutical company focused on the discovery, acquisition and development of novel drug candidates for central nervous system disorders. The Company's product candidates address some of the largest pharmaceutical markets in the world including insomnia, pain and depression.
      Cautionary Note
      Statements in this press release that are not historical facts constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act, each as amended, including statements regarding our expectations with respect to the progress of and level of expenses for our clinical trial programs. You can also identify forward-looking statements by the following words: may, will, should, expect, intend, plan, anticipate, believe, estimate, predict, potential, continue or the negative of these terms or other comparable terminology. We caution you that forward-looking statements are inherently uncertain and are simply point-in-time estimates based on a combination of facts and factors currently known by us about which we cannot be certain or even relatively confident. Actual results or events will surely differ and may differ materially from our forward-looking statements as a result of many factors, some of which we may not be able to predict or may not be within our control. Such factors may also materially adversely affect our ability to achieve our objectives and to successfully develop and commercialize our product candidates, including our ability to:
      Avatar
      schrieb am 31.08.06 18:33:50
      Beitrag Nr. 14 ()
      :D

      übrigens -
      schaut euch einmal den Insiderkauf des Direktors an.
      Der hat 2,32$ pro Aktie hingelegt.
      Ist das ein Volldepp??



      oder ein schlauer Fuchs?
      just wait and see...
      Mn
      Avatar
      schrieb am 07.09.06 23:48:11
      Beitrag Nr. 15 ()
      wird langwierig und gehört hierher:

      Neurocrine Plans New Test

      By Robert Steyer
      TheStreet.com Staff Reporter
      9/5/2006 5:22 PM EDT

      Neurocrine Biosciences (NBIX - commentary - Cramer's Take) dropped Tuesday after the company said it has to conduct another test for one version of its experimental insomnia drug Indiplon.

      Neurocrine predicted that it would resubmit its application for an immediate-release version of Indiplon before the end of the second quarter of 2007. Several analysts said the news appeared positive for this version of the drug, which received conditional approval from the Food and Drug Administration in May.

      " [The] good news is there were no unexpected potential downside surprises from the FDA meeting," says Eun K. Yang of Jeffries & Co. in a research note. "But Indiplon immediate-release's low commercial value is unlikely to drive valuation."

      Yang, who has a underperform rating on the stock, says the best-case scenario for immediate-release Indiplon would be final FDA approval by late 2007. But Yang believes the FDA's clearance won't come until late 2008. Yang doesn't own shares.

      However, analysts say the more significant news will be the FDA verdict on an extended-release version of Indiplon, which the agency initially rejected. Neurocrine has said this drug would likely need additional clinical testing. The long-acting version has been considered by Wall Street as a more attractive revenue-producing candidate. Indiplon executives plan to meet with the FDA in late October to discuss the product.
      The additional clarity -- even the requirement of additional testing -- on Indiplon is a welcome change to the announcements in May and June that caused a sharp drop in Neurocrine's stock and the termination by Pfizer (PFE - commentary - Cramer's Take) of an agreement to market Indiplon.

      The new test will cover how the drug interacts with certain foods and will be part of a resubmitted application. Gary Lyons, the president and CEO, said he expects to resolve outstanding issues "in the coming weeks."

      Neurocrine's stock was off 38 cents, or 3.5%, to $10.55, or about $2 better than its 52-week low. The 52-week high is $73.13.

      Analysts say the delay in getting either version of Indiplon to market will hurt Neurocrine thanks to the strength of existing brand-name drugs, the expected emergence later this year of generic copies of Sanofi-Aventis' (SNY - commentary - Cramer's Take) Ambien and development of several experimental drugs from other companies in late-stage clinical testing.

      "We still believe in the approvability of Indiplon as a molecule, though our assumptions for timing of the [extended-release] version are still somewhat speculative," says David Woodburn, of Prudential Equity Group, in a report to clients in which he maintains a neutral rating.

      "This lack of visibility doesn't help, knowing that Merck (MRK - commentary - Cramer's Take) is supposed to be filing its sleep drug gaboxadol in early 2007," says Woodburn, who doesn't own shares and whose firm doesn't have an investment banking relationship.

      Woodburn adds that several Big Pharma companies -- GlaxoSmithKline (GSK - commentary - Cramer's Take), Sanofi-Aventis and Pfizer -- are in late stages of developing insomnia drugs. He says Neurocrine's immediate-release version of Indiplon could reach the market in April 2008.

      But M. Ian Somaiya, of Thomas Weisel Partners, predicts Neurocrine will wait for the FDA to act on both the immediate-release and extended-release version of Indiplon. Additional clinical trials for the latter will push the application back until mid-2007, he tells clients.

      That means Indiplon won't hit the market until 2008, says Somaiya, who has a peer-perform rating on Neurocrine. He doesn't own shares, but his firm expects to receive or seek investment-banking compensation in the next three months.
      Avatar
      schrieb am 08.09.06 09:14:27
      Beitrag Nr. 16 ()
      Antwort auf Beitrag Nr.: 23.816.909 von Extrabreit am 07.09.06 23:48:11Das gibt DOVP eine Überlebenschance -

      kurzfristig wichtiger ist hier aber, ob das Delisting noch vermieden werden kann. Der Termin hierfür ist überfällig - soweit ich weiss, noch keine Entscheidung.
      Avatar
      schrieb am 08.09.06 09:19:42
      Beitrag Nr. 17 ()
      Antwort auf Beitrag Nr.: 23.818.426 von loseit am 08.09.06 09:14:27;)

      siehe #13


      die shorties sind raus

      nun helfen nur noch echte Käufer!
      Gruss
      Mn
      Avatar
      schrieb am 08.09.06 10:59:55
      Beitrag Nr. 18 ()
      Antwort auf Beitrag Nr.: 23.818.548 von Maroon am 08.09.06 09:19:42Hi, wie kommt man zu dieser tollen Übersicht?

      Gruss Loseit :cool:
      Avatar
      schrieb am 17.09.06 21:03:49
      Beitrag Nr. 19 ()
      Antwort auf Beitrag Nr.: 23.820.410 von loseit am 08.09.06 10:59:55so:

      http://www.nasdaq.com/asp/quotes_full.asp?mode=&kind=shortin…

      Gruss
      Avatar
      schrieb am 18.09.06 11:08:51
      Beitrag Nr. 20 ()
      Antwort auf Beitrag Nr.: 24.007.152 von Maroon am 17.09.06 21:03:49Danke!

      In der Sache bewegt sich hier m.A. erst was nach dem Indiplon-Entscheid.

      Mich wundert, dass noch keine Nasdaq-Entscheidung bzgl. Delisting gekommen ist. Evlt. erst nach Indiplon?

      Gruss Loseit :cool:
      Avatar
      schrieb am 10.10.06 15:54:41
      Beitrag Nr. 21 ()
      :rolleyes:

      http://biz.yahoo.com/prnews/061010/nytu117.html?.v=71

      Press Release Source: DOV Pharmaceutical, Inc.


      DOV Pharmaceutical, Inc. Announces New Strategic Direction, Bicifadine Clinical Studies Results and Program Updates
      Tuesday October 10, 9:20 am ET
      Company Announces Data for Phase III Trial in Chronic Low Back Pain and Phase II in OA


      SOMERSET, N.J., Oct. 10 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc. (Nasdaq: DOVP - News) announced today that it plans to implement a new strategic direction in which the Company will focus its internal efforts on its Phase I and II clinical and preclinical research programs for the development and discovery of drugs to treat neuropsychiatric disorders, advance the Company's later-stage drug development programs through external partnerships and collaborations, and optimize the Company's financial position. As a result of this new strategic direction, DOV will further reduce its cash expenditures. DOV has also been actively working with investment banking firm HSBC Securities (USA), Inc. to identify and evaluate its strategic options.
      ADVERTISEMENT





      "We have been faced with many challenges this year and have been working tirelessly to determine how to address these challenges and offer our stakeholders a value-driven strategic plan," said Barbara Duncan, President and Chief Financial Officer of DOV. "We believe that our decision to focus on the development of products emanating from our core areas of research and early stage clinical programs will significantly reduce our cash burn while we continue to evaluate strategic options for the Company."

      DOV Strategic Direction - Focus on Core Pipeline

      Currently, DOV has drug development programs that are at the preclinical, Phase I, Phase II and Phase III clinical stages. These include bicifadine (Phase III for analgesia), DOV 21,947 (entering Phase II for depression), DOV 102,677 (Phase I for alcohol abuse) and an active preclinical discovery program in reuptake inhibitors and GABA modulators. DOV, while continuing to develop these core research platforms, will reduce its in-house late stage clinical development expenditures.

      DOV's reuptake inhibitor platforms, including TRIs (triple reuptake inhibitors), NEDs (norepinephrine and dopamine reuptake inhibitors), and SADs (serotonin and dopamine reuptake inhibitors) have been tailored to treat a wide variety of neuropsychiatric disorders ranging from depression and attention deficit hyperactivity disorder to pain and obesity. In addition to DOV 21,947 and DOV 102,677, the Company has several molecules in various stages of preclinical development.

      The primary objective of the GABA modulator program remains the development of a molecule producing a robust anti-anxiety action without the side effects associated with benzodiazepines such as diazepam (Valium®). Several molecules fitting this profile are in various stages of preclinical development. Further, GABA modulators also have proven utility as sedative- hypnotics, anticonvulsants, and muscle relaxants, and the Company has discovered several unique structural platforms that may be developed for these indications.

      "DOV has deep scientific expertise in both the reuptake inhibitor and GABA modulator platforms and it is our objective to identify and bring forward the most promising clinical candidates in these core research areas," said Dr. Phil Skolnick, Executive Vice President and Chief Scientific Officer of DOV.

      DOV Partnership with Merck for DOV 21,947 and DOV 216,303

      DOV is also announcing today that it has notified Merck of its desire to terminate the companies' license agreement with respect to DOV 21,947. As a result of this notification and in the event Merck decides not to re-internalize DOV 21,947, DOV will regain all rights to the compound, which will help the Company to increase its focus on its reuptake inhibitor program and also enable DOV to pursue broad partnership opportunities with respect to this program as part of its new strategic direction. As Merck notified DOV that it did not intend to select a preclinical compound licensed for evaluation under the amendment to the license agreement, all rights and data from those compounds will be returned to DOV effective immediately. DOV has asked Merck to notify the Company by December 8, 2006 about Merck's decision regarding the re-internalization and assumption of all development and other rights and obligations in the license agreement with respect to DOV 21,947. In the event Merck decides not to re-internalize the compound, DOV 21,947 will no longer be covered by the license agreement effective as of December 8, 2006. Unless terminated by Merck, the license agreement will remain effective in respect to DOV 216,303.

      Partnering of Bicifadine

      DOV will continue to seek a partner to further develop bicifadine, which has been shown to be effective in treating pain in three placebo-controlled efficacy trials in more than 1,600 patients with acute post-surgical pain. DOV also has conducted three substantial Phase III clinical trials of bicifadine in Chronic Low Back Pain (CLBP) and one early Phase II trial of bicifadine in osteoarthritis, all of which have provided the Company with a significant amount of data about the efficacy and safety of the drug. Bicifadine has demonstrated an attractive safety profile in short- and long- term safety studies involving more than 3,000 patients. Also, DOV has completed lifetime carcinogenicity studies in rats and mice with no meaningful signals of carcinogenicity detected after two years of testing, an outcome that DOV expects to be acceptable to the FDA.

      DOV is holding discussions with potential partners for the further development and commercialization of bicifadine. DOV is working towards structuring licensing terms with potential partners utilizing the new information gathered from the Company's clinical trials of bicifadine -- the placebo-controlled Phase III trial, study 021, and the Phase II osteoarthritis study. Descriptions of the clinical trial results from the interim analyses of these two studies are included in this press release.

      Patent Issuance

      In April 2006, DOV announced that the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for its patent application covering a new polymorphic, or crystalline, form of its proprietary compound bicifadine, a novel analgesic. Today, the Company announces that this patent has been formally issued by the USPTO. Such patent will run through at least 2024 for this distinct form of bicifadine, which is the same form used in DOV's clinical trials and bicifadine development program.

      DOV Partnership with Neurocrine for Indiplon

      DOV retains its license relationship with Neurocrine for the development of indiplon for the treatment of insomnia. Through this partnership, DOV will receive a 3.5 percent worldwide royalty on any sales of indiplon. In September 2006, Neurocrine held an end-of-review meeting with the Food and Drug Administration (FDA) for the indiplon capsules New Drug Application (NDA). Neurocrine summarized the results of the FDA meeting as follows: the FDA requested that Neurocrine supplement the pharmacokinetic/food effect profile of indiplon (IR) capsules to include several meal types. Neurocrine announced that it will initiate such a study shortly after further consultation with the FDA and that no other clinical trials were requested for the re-submission. Neurocrine also announced that it will hold an end-of- review meeting with the FDA to discuss and clarify action items for indiplon (MR) tablets towards late October 2006.

      DOV Diltiazem

      DOV Diltiazem, the Company's proprietary formulation of diltiazem, is a product candidate for the treatment of angina and hypertension. DOV diltiazem combines an immediate release component with a controlled release component which the Company believes will provide prompt and improved blood levels throughout the day compared to currently marketed diltiazem products. In August 2006, the Company reached agreement with the FDA on the scope and design of the clinical trials required for submission of an NDA for DOV diltiazem and is continuing to evaluate strategic alternatives for its development and commercialization.

      NASDAQ Listing

      DOV will meet with the NASDAQ Listing Qualifications Panel on October 19, 2006 to present its plan for regaining compliance with the $50 million market capitalization listing requirement set forth by The NASDAQ Global Market. DOV will continue to be traded on The NASDAQ Global Market until a determination is made by the NASDAQ Listing Qualifications Panel following the hearing. The Company will issue a press release once it receives the NASDAQ Listing Qualifications Panel decision.

      Furthermore, DOV announces today that it received a letter on October 5, 2006 from the NASDAQ Listing Qualifications Department notifying the Company that, for 30 consecutive business days, the price of DOV's common stock has closed below the minimum $1.00 per share requirement for continued inclusion, as set forth in NASDAQ Marketplace Rule 4450(b)(4). DOV, in accordance with Marketplace Rule 4450(c)(2), has been provided 180 calendar days -- or until April 3, 2007 -- to regain compliance. DOV intends to provide the Panel with its plan for regaining compliance with the bid price requirement by the April 3, 2007 deadline at the hearing.

      In the event the Company does not remain listed on a U.S. national securities exchange, the Company will be required to offer to repurchase the Company's $70 million outstanding convertible subordinated debentures.


      Program Updates
      Bicifadine, the Company's Novel Analgesic

      Study 021
      Study 021 is a double-blind, placebo-controlled trial of bicifadine in patients with chronic low back pain (CLBP). After reviewing the detailed analysis of its first Phase III trial of bicifadine in CLBP -- study 020 -- DOV announced that it amended the inclusion criteria and simplified the dosing regimen of this second ongoing Phase III trial -- study 021 -- of bicifadine in CLBP to better position the trial for a successful outcome. Study 021, therefore, was amended to analyze only patients with more severe CLBP, accompanied by pain radiating to the leg and/or substantial functional disability, and compare only two dosing arms, 400 mg of bicifadine versus placebo.

      Study 021 has enrolled more than one half of the intended patients. DOV has recently elected to perform an interim analysis and to unblind the results to determine whether the baseline features of functional disability or back pain plus radiating leg pain would result in the selection of patients for whom the placebo response is low and the bicifadine effect is substantial. Additionally, DOV performed a meta-analysis of the combined study 020 (for which data was released in April 2006) and study 021 of bicifadine in CLBP patients, thus providing a larger sample size upon which to draw conclusions regarding the efficacy of bicifadine in CLBP.

      The importance of radiating leg pain (Quebec Classification (QC) of 2 or 3 for low back pain) at baseline was observed as a predictor of a low placebo response in study 020, but did not replicate in study 021. Both the meta- analysis of the combined study results and the results of study 021 did not show statistically significant superiority for controlling low back pain in patients enrolled with these baseline characteristics. Thus, DOV no longer believes that this baseline factor of radiating leg pain is a basis for selecting patients for whom the placebo response is low in future trials.

      However, the meta-analysis did demonstrate that for those patients with a moderate-to-severe level of dysfunction due to CLBP (Roland Morris Disability (RDQ) scores >17 at baseline), bicifadine showed statistically superior effects (p<0.05) at the 400 mg dose as well as all dose levels combined versus placebo in reducing back pain. The 021 results on this measure showed a strong tendency for this effect, but the combination of the moderate effect size and the modest sample size led to a statistically insignificant result. Based on the positive outcome of the meta-analysis of the combined 020 and 021 studies for the patients with baseline RDQ values >17 (n=219), DOV intends to meet with the FDA to discuss regulatory strategy and the scope of the future product labeling using this patient selection criterion. The Company believes this clarification will facilitate its bicifadine partnering efforts.

      In order to best allocate resources, DOV will stop patient dosing in study 021. However, as it is an FDA requirement to complete the relevant safety assessments for ongoing patients, the Company anticipates completion of all patient dosing and post-dosing safety assessments in November 2006. The Company will concurrently work to clean its study database and close out the trial. More detailed trial results are expected to be announced shortly thereafter.

      Study 022

      DOV has previously announced that enrollment in its Phase III open-label, long-term safety trial -- study 022 -- had been completed. To date, more than 175 patients have completed six months of dosing and more than 30 patients have completed a full year of treatment with bicifadine. There have been no deaths in the more than 3,000 patients who have received bicifadine in the clinical trial program. Further, there are no apparent safety risks in respect to cardiovascular safety and liver function, organ systems that are most commonly the cause of drug related safety concerns. As the safety database is no longer the gating item to an NDA filing and in order to further reduce cash burn, DOV has elected to stop dosing of all ongoing patients. This process and related regulatory close-out obligations at the study sites will take several months and is expected to be completed by early 2007.

      Phase II Trial in Osteoarthritis

      DOV has performed an interim analysis of the results from the 29 patients who have completed all four dosing arms in its ongoing Phase II study of bicifadine in subjects with osteoarthritis of the hip or knee. This Phase II trial is the first study of bicifadine in patients with osteoarthritis. The trial, a multi-center, double-blind, placebo-controlled, four-way crossover trial in approximately 36 patients, is designed to assess the efficacy, tolerability and pharmacokinetics of bicifadine alone and in combination with ibuprofen. Dosing will be completed in mid-October.

      The mean improvement scores on the primary efficacy endpoint (WOMAC total score) for the patients taking a combination of bicifadine plus ibuprofen were clinically and statistically superior to the improvement scores seen in the placebo (p<0.0001), bicifadine (p<0.001) and ibuprofen (p<0.05) groups. The improvement seen after only one week of dosing with bicifadine plus ibuprofen relative to placebo is appreciably larger than in many previously-reported placebo-controlled trials for COX-2 inhibitors or other NSAIDs in which dosing lasted for up to three months. This significant and substantial improvement in pain reduction after only one week represents an unexpected finding using bicifadine and an NSAID, in this case ibuprofen. Ibuprofen alone was superior to placebo (p<0.05), whereas one week of dosing with bicifadine alone was not. The marked benefits seen with concurrent dosing of bicifadine plus ibuprofen were not due to a pharmacokinetic interaction between the two drugs since neither bicifadine nor ibuprofen appreciably altered the blood levels of the other drug.

      The Company expects the substantial efficacy demonstrated in this trial for treating the pain associated with OA of the hip or knee by the concurrent dosing of bicifadine plus ibuprofen treatment will facilitate partnering discussions with respect to the development of a combination product for this indication.

      About DOV

      DOV is a biopharmaceutical company focused on the discovery, acquisition and development of novel drug candidates for central nervous system disorders. The Company's product candidates address some of the largest pharmaceutical markets in the world including depression, pain and insomnia.

      Cautionary Note

      Statements in this press release that are not historical facts constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act, each as amended, including statements regarding our expectations with respect to the progress of and level of expenses for our clinical trial programs. You can also identify forward-looking statements by the following words: may, will, should, expect, intend, plan, anticipate, believe, estimate, predict, potential, continue or the negative of these terms or other comparable terminology. We caution you that forward-looking statements are inherently uncertain and are simply point-in-time estimates based on a combination of facts and factors currently known by us about which we cannot be certain or even relatively confident. Actual results or events will surely differ and may differ materially from our forward-looking statements as a result of many factors, some of which we may not be able to predict or may not be within our control. Such factors may also materially adversely affect our ability to achieve our objectives and to successfully develop and commercialize our product candidates, including our ability to:


      * comply with the continued listing requirements of The NASDAQ Global
      Market and successfully appeal the NASDAQ Staff determination;

      * raise substantial additional capital, including in the event our common
      stock is no longer listed for trading on a U.S. national securities
      exchange, in order to fund operations and, if applicable, to repurchase
      our convertible subordinated debentures;

      * obtain and maintain all necessary patents, licenses and other
      intellectual property rights;

      * demonstrate the safety and efficacy of product candidates at each stage
      of development;

      * develop and execute clinical programs for bicifadine, our novel
      analgesic;

      * meet our development schedule for our product candidates, including with
      respect to clinical trial initiation, enrollment and completion;

      * meet applicable regulatory standards and receive required regulatory
      approvals on our anticipated time schedule or at all;

      * meet or require our partners to meet obligations and achieve milestones
      under our license and other agreements;

      * obtain and maintain collaborations as required with pharmaceutical
      partners;

      * obtain substantial additional funds; and

      * produce drug candidates in commercial quantities at reasonable costs and
      compete successfully against other products and companies.

      You should also refer to the risks discussed in our other filings with the Securities and Exchange Commission including those contained in our annual report on Form 10-K filed on March 15, 2006 and our quarterly report on Form 10-Q filed on August 9, 2006. We qualify all our forward-looking statements by these cautionary statements. Readers should not place undue reliance on our forward-looking statements. We do not undertake any obligation and do not intend to update any forward-looking statement.




      --------------------------------------------------------------------------------
      Source: DOV Pharmaceutical, Inc.
      Avatar
      schrieb am 17.10.06 17:56:04
      Beitrag Nr. 22 ()
      Sell Off beendet? Zumindest gehts heute unter hohen Umsätzen aufwärts.

      Meiner Meinung nach ist der Boden gefunden.

      Gruß
      Avatar
      schrieb am 17.10.06 18:01:14
      Beitrag Nr. 23 ()
      Antwort auf Beitrag Nr.: 24.684.205 von Extrabreit am 17.10.06 17:56:04Interessant wäre noch, warum eigentlich? :rolleyes:
      Im Yahoo-Board nix Konkretes, weiss einer mehr?
      Avatar
      schrieb am 25.10.06 18:33:54
      Beitrag Nr. 24 ()
      minus 24% bis auf null?

      Oct 25 (Reuters) -

      DOV PHARMACEUTICAL INC. (DOVP.O: Quote, Profile, Research)

      Current Prior Rating Sell Hold Price target $0.00 $1.10

      --Citigroup said it expects the company to be delisted from the Nasdaq in 1-7 days. If delisted, DOV has 15 days to notify its bondholders and 30 days to offer to pay its $70 million convertible debt at par.

      --Citigroup said given the biopharmaceutical company had about $60 million in cash at the end of the second quarter, DOV will be facing bankruptcy unless it can re-negotiate the terms of its debt with the bondholders. The brokerage noted that bondholders have first ownership right in the company ahead of equity holders. (Reporting by Aditya Phatak in Bangalore)


      sieht nicht gut aus.
      Avatar
      schrieb am 25.10.06 19:10:45
      Beitrag Nr. 25 ()
      Antwort auf Beitrag Nr.: 24.850.068 von Extrabreit am 25.10.06 18:33:54:rolleyes:

      Wahnsinn -
      von 20 auf 0,50 ohne einen Rebound.
      97,5% Verlust in 8 Monaten...

      Avatar
      schrieb am 25.10.06 19:15:33
      Beitrag Nr. 26 ()
      bin raus mit meinen 500 Stück. werde den Wert erstmal beobachten.

      eine Erholung dürfte momentan nur durch eine Übernahme erfolgen,
      und dsa habe ich aktuell wenig Hoffnung.

      Schade


      Gruß Extrabreit
      Avatar
      schrieb am 25.10.06 19:30:57
      Beitrag Nr. 27 ()
      Antwort auf Beitrag Nr.: 24.851.045 von Extrabreit am 25.10.06 19:15:33;)

      400 davon hab ich nun...

      sehe die Aktie als Optionsschein -
      entweder mehrere 100% Gewinn, oder sero.
      Gruss
      Avatar
      schrieb am 26.10.06 16:43:40
      Beitrag Nr. 28 ()
      eigentlich ist alles bekannt:

      Oct 26 (Reuters) - DOV Pharmaceutical Inc. (DOVP.O: Quote, Profile, Research) on Thursday said it will be delisted from Nasdaq.

      In a statement, the company said the Nasdaq Listing Qualifications Panel decided to delist its securities from Oct. 27 for failing to meet the minimum market value of listed securities.

      The company said it is considering strategic options. (Reporting by Shikhar Balwani in Bangalore)


      ab Montag könnte es nochmals kräftig abwärts laufen
      unter 0,15 versuchs ich nochmal
      Avatar
      schrieb am 26.10.06 18:26:28
      Beitrag Nr. 29 ()
      Avatar
      schrieb am 26.10.06 18:27:05
      Beitrag Nr. 30 ()
      Avatar
      schrieb am 26.10.06 18:27:41
      Beitrag Nr. 31 ()
      Avatar
      schrieb am 26.10.06 18:32:44
      Beitrag Nr. 32 ()


      Man das funzt heute alles erst wieder nach dem 2 ten Anlauf. :mad:
      Avatar
      schrieb am 03.11.06 18:45:47
      Beitrag Nr. 33 ()
      Nach diesen News nehme ich DOVP.Pk auch von meiner Watchlist.

      Adios.

      Drug Delay Drubs Neurocrine

      By Robert Steyer
      TheStreet.com Staff Reporter
      11/3/2006 12:33 PM EST
      Click here for more stories by Robert Steyer

      Neurocrine Biosciences (NBIX - commentary - Cramer's Take - Rating) saw its shares tumble Friday, a day after the company reported another delay for its experimental insomnia drug Indiplon.

      On Thursday after the markets had closed, Neurocrine said it would seek government approval of an immediate-release version of Indiplon during the summer of 2008. In September, it predicted it would file an application for clearance with the Food and Drug Administration by the second quarter of 2007.

      Following the announcement, shares of San Diego-based Neurocrine plunged $3.37, or 30.6%, to $7.66, a 52-week low. Trading volume was heavy.

      The FDA granted conditional approval in May for the immediate-release capsules. At the same time, the agency rejected Neurocrine's application for extended-release tablets. Analysts had forecast that extended-release Indiplon would have a greater sales potential because it was designed to help people stay asleep rather than just to help them fall asleep.

      A month after the FDA ruling, Pfizer (PFE - commentary - Cramer's Take - Rating) cancelled its marketing deal with Neurocrine. Both events crushed Neurocrine's stock, whose high for the past year is $73.13.

      The agency's conditions for approving immediate-release capsules included the need for Neurocrine to conduct additional analyses of data previously submitted to the agency. The company is continuing that work. The FDA also asked Neurocrine to conduct another test on how the drug is absorbed and excreted by the body and how it reacts with certain foods.

      The FDA didn't want more clinical studies, but the company will conduct another three-month trial of the immediate-release drug's safety and efficacy in helping people fall asleep. The FDA does want more long-term safety and effectiveness studies for the extended-release tablets and the development of a separate dose for older people.

      "Now that we have received clarification from the FDA on the requirements for Indiplon, we believe that Indiplon will be best served by focusing our resources on the resubmission of the [application] to secure approval for [immediate-release] capsules," CEO Gary Lyons said Thursday.

      Conducting another clinical trial on helping people fall asleep will "ensure the highest probability for the success" for the application, he added. "We will be pursuing a sleep-maintenance claim for Indiplon to be filed as a separate application at a later date."

      Neurocrine also released third-quarter financial results. For the three months ended Sept. 30, the company lost $39.1 million, or $1.03 a share, reversing a profit of $26.2 million, or 71 cents a share, for the same period last year. EPS figures exclude accounting for share-based compensation. Neurocrine took a one-time charge of $9.5 million during the recent quarter for severance and outplacement costs.

      Third-quarter revenue dropped to $1.1 million from $64.7 million due primarily to a $50-million milestone payment from Pfizer during the year-ago quarter. Neurocrine expects to end 2006 with $180 million in cash, cash equivalents and marketable securities. It will have spent $100 million by year-end, and it expects to spend $80 million next year.

      "We have reallocated resources and adjusted operating expenses in order to meet the funding requirements for continued development of our pipeline," Timothy P. Coughlin, the chief financial officer, said in a prepared statement. "We plan to continue to maintain a well-controlled [cash] burn rate and will also review collaborative alternatives and outside funding strategies to achieve these goals."

      Neurocrine is conducting clinical trials on several other compounds, including treatments for endometriosis, congestive heart failure and irritable bowel syndrome.
      Avatar
      schrieb am 05.12.06 21:29:31
      Beitrag Nr. 34 ()
      Antwort auf Beitrag Nr.: 25.109.280 von Extrabreit am 03.11.06 18:45:47:rolleyes:

      heute ein Lebenszeichen!?
      Nach 99% Kursverlust ohne Rebound!

      Avatar
      schrieb am 05.12.06 22:21:23
      Beitrag Nr. 35 ()
      Avatar
      schrieb am 06.12.06 16:50:19
      Beitrag Nr. 36 ()
      Antwort auf Beitrag Nr.: 25.962.717 von GerdKill am 05.12.06 22:21:23:D

      na also -
      hier hat sich die Geduld gelohnt...
      Hälfte raus und evtl in ein paar Tagen Nachkauf...
      Avatar
      schrieb am 06.12.06 16:51:23
      Beitrag Nr. 37 ()
      Avatar
      schrieb am 06.12.06 18:43:05
      Beitrag Nr. 38 ()


      Beitrag zu dieser Diskussion schreiben


      Zu dieser Diskussion können keine Beiträge mehr verfasst werden, da der letzte Beitrag vor mehr als zwei Jahren verfasst wurde und die Diskussion daraufhin archiviert wurde.
      Bitte wenden Sie sich an feedback@wallstreet-online.de und erfragen Sie die Reaktivierung der Diskussion oder starten Sie
      hier
      eine neue Diskussion.
      3$ für ein halleluja.....