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    eröffnet am 21.07.00 17:42:54 von
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     Ja Nein
      Avatar
      schrieb am 21.07.00 17:42:54
      Beitrag Nr. 1 ()
      ... Leute, was macht ihr mit Calypte Biomedicals (WKN 909402; NASDAQ-Kürzel CALY)? Das ist ein Biotechwert der schon Gewinne macht, die Biotech Rallye noch nicht mitgemacht hat und äußerst billig bewertet ist!

      Legt euch davon was ins Depot, denn leichter kann man nicht 1000% (*g*) machen!

      Grüße
      Norman
      Avatar
      schrieb am 21.07.00 17:46:08
      Beitrag Nr. 2 ()
      Was haben die den in der Medikamentenpipeline?

      Thx skilly
      Avatar
      schrieb am 21.07.00 17:52:56
      Beitrag Nr. 3 ()
      Tipp: http://www.calypte.com ;)

      normi*
      Avatar
      schrieb am 21.07.00 18:03:48
      Beitrag Nr. 4 ()
      Factors That May Affect Future Results, Events, or Performance
      Calypte has identified a number of risk factors and uncertainties that it faces. These factors, among others, may cause actual results, events, or performance to differ materially from those expressed in any forward-looking statements we make in this Form 10Q or in press releases or other public disclosures. Investors should be aware of the existence of these factors.

      Uncertain Market Acceptance of Our New Method of Determining the Presence of HIV Antibodies
      Our products incorporate a new method of determining the presence of HIV-1 antibodies. There can be no assurance that we will obtain:

      • any significant degree of market acceptance among physicians, patients, or healthcare payors
      • recommendations and endorsements by the medical community that are essential for market acceptance of the products

      We have FDA approval to market our urine HIV-1 screening and supplemental tests in the United States and have been marketing these products since July 1998. To date, however, this testing method has generated only limited revenues and not achieved significant market penetration. The failure of our products to obtain market acceptance would have a material adverse effect on us.

      We Have Limited Experience Selling and Marketing Our HIV-1 Urine-Based Screening Test.
      We have little experience marketing and selling our products either directly or through our distributors. The success of our products depends upon alliances with third-party distributors, including the distribution agreement announced in September 1999 with Carter-Wallace Inc. There can be no assurance that:
      • our direct selling efforts will be effective
      • our distributors will successfully market our products
      • if our relationships with distributors terminate, we will be able to establish relationships with other distributors on satisfactory terms, if at all


      Any disruption in our distribution, sales, or marketing network could have a material adverse effect on us.

      We Have Sustained Losses in the Past, and We Expect to Sustain Losses in the Future.
      We have incurred losses in each year since our inception. Our net loss for the quarter ended March 31, 2000 was $2.2 million, and our accumulated deficit as of March 31, 2000 was $69.0 million. We expect operating losses to continue as we continue our marketing and sales activities for our FDA-approved products and conduct additional research and development for product and process improvements and new products.

      Our Quarterly Results May Fluctuate Due to Certain Regulatory, Marketing, and Competitive Factors over Which We Have Little or No Control.
      The factors listed below, some of which we cannot control, may cause our revenues and results of operations to fluctuate significantly:
      • actions taken by the FDA or foreign regulatory bodies relating to our products
      • the extent to which our products and our Sentinel™ HIV and STD testing service gain market acceptance
      • the timing and size of distributor purchases
      • introductions of alternative means for testing for HIV-1 by competitors


      We May Not Be Able to Obtain Additional Financing That We May Need in the Future.
      The report of KPMG LLP covering the December 31, 1999 consolidated financial statements contains an explanatory paragraph that states that our recurring losses from operations and accumulated deficit raise substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of that uncertainty. We may need to raise more money to continue to finance our operations. We may not be able to obtain additional financing on acceptable terms, or at all. Any failure to raise additional financing, if needed, will likely place us in significant financial jeopardy.

      We Depend upon the Viability of Three Products: Our HIV-1 Urine-Based Screening Test and Our Urine- and Blood-Based Supplemental Tests.
      Our HIV-1 urine-based screening test and urine and blood-based supplemental tests are our only products. Accordingly, we may have to cease operations if our tests fail to achieve market acceptance or generate significant revenues.

      Our Products Depend upon Rights to Technology That We Have Licensed from Third-Party Patent Holders and There Can Be No Assurance That the Rights We Have under These Licensing Agreements Are Sufficient or That We Can Adequately Protect Those Rights.
      We currently have the right to use patent and proprietary rights that are material to the manufacture and sale of our HIV-1 urine-based screening test under licensing agreements with New York University, Cambridge Biotech Corporation, Repligen, and the Texas A&M University System.

      We Rely on Sole-Source Suppliers That We Cannot Quickly Replace for Certain Components Critical to the Manufacture of Our Products.
      Any delay or interruption in the supply of these components could have a material adverse effect on us by significantly impairing our ability to manufacture products in sufficient quantities, particularly as we increase our manufacturing activities in support of commercial sales.

      We Have Limited Experience in Manufacturing Our Products and Little Experience in Manufacturing Our Products in Commercial Quantities.
      We may encounter difficulties in scaling up production of new products, including problems involving:
      • production yields
      • quality control and assurance
      • raw material supply
      • shortages of qualified personnel


      The Success of Our Plans to Enter International Markets May Be Limited or Disrupted Due to Risks Related to International Trade and Marketing and the Capabilities of Our Distributors
      We anticipate that international distributor sales will generate a significant portion of our revenues for the next several years. We believe that our urine-based test can provide significant benefits in countries that do not have the facilities or personnel to safely and effectively collect and test blood samples. The following risks may limit or disrupt our international sales:
      • the imposition of government controls
      • export license requirements
      • political instability
      • trade restrictions
      • changes in tariffs
      • difficulties in managing international operations
      • fluctuations in foreign currency exchanges rates


      Some of our distributors have limited international marketing experience. There can be no assurance that these distributors will be able to successfully market our products in foreign markets.

      We Face Intense Competition in the Medical Diagnostic Products Market and Rapid Technological Advances by Competitors.
      Competition in our diagnostic market is intense, and we expect it to increase. Within the United States, our competitors include a number of well-established manufacturers of HIV tests using blood samples, plus at least one system for the detection of HIV antibodies using oral fluid samples. Many of our competitors have significantly greater financial, marketing, and distribution resources than we do. Our competitors may succeed in developing or marketing technologies and products that are more effective than ours. These developments could render our technologies or products obsolete or noncompetitive or otherwise have a material adverse effect on us.

      Our Ability to Market Our Products Depends upon Obtaining and Maintaining FDA and Foreign Regulatory Approvals.
      Numerous governmental authorities in the United States and other countries regulate our products. The FDA regulates our products under federal statutes and regulations related to pre-clinical and clinical testing, manufacturing, labeling, distribution, sale, and promotion of medical devices in the United States.

      If we fail to comply with FDA regulations, or the FDA believes that we are not in compliance with such regulations, the FDA can:
      • detain or seize our products
      • issue a recall of our products
      • prohibit marketing and sales of our products
      • assess civil and criminal penalties against us, our officers, or our employees


      We also plan to sell our products in certain foreign countries where they may be subject to similar local regulatory requirements. The imposition of any of the sanctions described above could have a material adverse effect on us.

      The regulatory approval process in the United States and other countries is expensive, lengthy, and uncertain. We may not obtain necessary regulatory approvals or clearances in a timely manner, if at all. We may lose previously obtained approvals or clearances or fail to comply with regulatory requirements. The occurrence of any of these events would have a material adverse effect on Calypte.

      Before we begin to manufacture our product at the Alameda facility, we must obtain FDA approval for that facility. Delays in receiving the FDA`s approval or other difficulties which we encounter in scaling up our manufacturing capacity to meet demand could have a material adverse effect on us.

      Sufficiency of Our Manufacturing Records and Production Procedures and Satisfying the FDA`s Concerns in Order to Avoid Regulatory Action Against Us
      In November 1998, the Company received a Warning Letter from the FDA following an inspection by the FDA of the Company`s manufacturing facilities in Berkeley and Alameda, California. On December 11, 1998, the Company responded in writing to each of the deficiencies cited in the Warning Letter. The Company subsequently received another letter from the FDA requesting further responses regarding certain of the deficiencies. The Company responded to the subsequent letter on June 1, 1999. The FDA conducted a follow-up inspection of the Berkeley and Alameda facilities from September 28 through October 7, 1999, which resulted in observations requiring corrective action or response from the Company. The Company submitted its written responses to the FDA`s inspection observations on November 4, 1999. On March 21, 2000, the Company received a response from the FDA requesting additional information. Company representatives met with and provided information to FDA officials on April 27, 2000 and on May 5, 2000 responded in writing to requests for additional information. Additionally, the FDA has granted a meeting with Company representatives on May 16, 2000 to review and provide comments on the Company`s application for its Alameda facility.

      In May 1999, the Company received a Warning Letter from the FDA that cited a number of significant observations related to its November 20 through December 11, 1998 inspection of the Company`s manufacturing plant in Rockville, Maryland. On May 24, 1999, the Company responded in writing to each of the deficiencies cited in the Warning Letter. On November 19, 1999, the Company received a letter from the FDA stating that the Company`s responses were considered adequate, and the Warning Letter was formally closed. Between November 30 and December 9, 1999, the FDA conducted a follow-up inspection of the Rockville facility that resulted in observations requiring corrective actions or response from the Company. On January 7, 2000, the Company responded in writing to each of the FDA`s observations and is awaiting the FDA`s reply. On March 21, 2000, the Company received a response from the FDA requesting additional information. Company representatives met with and provided information to FDA officials on April 27, 2000 and on May 5, 2000 responded in writing to requests for additional information.

      If the FDA is not satisfied with the Company`s responses and corrective actions regarding these matters at either its Alameda or Rockville facilities, the FDA could take regulatory actions against the Company, including license suspension, revocation, and/or denial, seizure of products and/or injunction, and/or civil penalties or criminal sanctions. Any such FDA action is likely to have a material adverse effect upon the Company`s ability to conduct operations. In addition, failure of the Company to satisfy the FDA on these matters may adversely affect receiving approval for manufacturing at the Alameda facility and/or the Company`s ability to export its products to certain international markets.

      As a Small Manufacturer of Medical Diagnostic Products, We Are Exposed to Product Liability and Recall Risks for Which Insurance Coverage Is Expensive, Limited, and Potentially Inadequate.
      We manufacture medical diagnostic products, which subjects us to risks of product liability claims or product recalls, particularly in the event of false positive or false negative reports. A product recall or a successful product liability claim or claims that exceed our insurance coverage could have a material adverse effect on us. We maintain a $10,000,000 claims-made policy of product liability insurance. However, product liability insurance is expensive. In the future we may not be able to obtain coverage on acceptable terms, if at all. Moreover, our insurance coverage may not adequately protect us from liability that we incur in connection with clinical trials or sales of our products.

      Our Charter Documents May Inhibit a Takeover.
      Certain provisions of our Certificate of Incorporation and Bylaws could:
      • discourage potential acquisition proposals
      • delay or prevent a change in control of Calypte
      • diminish stockholders` opportunities to participate in tender offers for our common stock, including tender offers at prices above the then current market price
      • inhibit increases in the market price of our common stock that could results from takeover attempts


      We Have Adopted a Shareholder Rights Plan That Has Certain
      Anti-Takeover Effects.
      On December 15, 1998, the Board of Directors of Calypte declared a dividend distribution of one preferred share purchase right ("Right") for each outstanding share of Common Stock of the Company. The dividend was payable to the stockholders of record on January 5, 1999 with respect to each share of Common Stock issued thereafter until a subsequent "distribution date" defined in a Rights Agreement and, in certain circumstances, with respect to shares of Common Stock issued after the Distribution Date.

      The Rights have certain anti-takeover effects. The Rights will cause substantial dilution to a person or group that attempts to acquire the Company without conditioning the offer on the Rights being redeemed or a substantial number of Rights being acquired. However, the Rights should not interfere with any tender offer or merger that is approved by the Company because the Rights do not become exercisable in the event of an offer or other acquisition exempted by Calypte`s Board of Directors.

      An Investor`s Ability to Trade Our Common Stock May Be Limited by
      Trading Volume.
      The trading volume in our common shares has been relatively limited. A consistently active trading market for our common stock may not develop.

      We May Be Removed from the NASDAQ SmallCap Market if We Fail to
      Meet Certain Maintenance Criteria.
      The NASDAQ Stock Market inquired on two occasions whether we continue to meet the net capital surplus maintenance criterion for trading on the NASDAQ SmallCap Market. We currently meet the maintenance criterion, but our ability to continue to do so will depend on whether we are able to maintain net tangible assets of $2,000,000 and whether the minimum bid price for our common stock exceeds $1.00 per share for at least 10 consecutive business days during any period of 120 consecutive business days. The public trading of our common stock and the ability of our stockholders to sell their shares could be significantly impaired if we fail to meet the maintenance criterion and are removed from the NASDAQ SmallCap Market. In that case, our common stock would trade on either the OTC bulletin board, a regional exchange, or in the pink sheets, which would likely result in an even more limited trading volume.

      The Price of Calypte`s Common Stock Has Been Highly Volatile Due to Several Factors Which Will Continue to Affect the Price of Our Stock.
      Our common stock has traded as low as $1.28 per share and as high as $7.25 per share during the first quarter of 2000. Some of the factors leading to the volatility include:
      • price and volume fluctuations in the stock market at large which do not relate to our operating performance
      • fluctuations in our operating results
      • announcements of technological innovations or new products that we or our competitors make
      • FDA and international regulatory actions
      • availability of reimbursement for use of our products from private health insurers, governmental health administration authorities, and other third-party payors
      • developments with respect to patents or proprietary rights
      • public concern as to the safety of products that we or others develop
      • changes in healthcare policy in the United States or abroad
      • changes in stock market analysts` recommendations regarding Calypte, other medical products companies, or the medical product industry generally


      Calypte and the Price of Calypte Shares May be Adversely Affected by the Public Sale of a Significant Number of the Shares Eligible for Future Sale.
      All outstanding shares of our common stock are freely tradable. Sales of common stock in the public market could materially adversely affect the market price of our common stock. Such sales also may inhibit our ability to obtain future equity or equity-related financing on acceptable terms.

      Our Research and Development of HIV-1 Urine Test Involves the Controlled Use of Hazardous Materials.
      There can be no assurance that our safety procedures for handling and disposing of hazardous materials such as azide will comply with applicable regulations. In addition, we cannot eliminate the risk of accidental contamination or injury from these materials. We may be held liable for damages from such an accident, and that liability could have a material adverse effect on us.

      We May Not Be Able to Retain Our Key Executives and Research and Development Personnel.
      As a small company with only 62 employees, our success depends on the services of key employees in executive and research and development positions. The loss of the services of one or more of such employees could have a material adverse effect on us.






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      © 2000 Calypte Biomedical | Terms & Conditions

      von der homepage.
      nicht uninteressant, aber seit 1 1/2 jahren am markt und nicht durchsetzungsfaehig???!!!
      Avatar
      schrieb am 21.07.00 18:10:30
      Beitrag Nr. 5 ()
      :laugh: sowas von selbstkritisch, dass einem die lust vergeht...
      aber wenigstens ehrlich die jungs, macht sie auf jeden fall sympathisch...

      gruß
      havok

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      Avatar
      schrieb am 21.07.00 18:14:56
      Beitrag Nr. 6 ()
      an soviel ehrlichkeit könnten sich unsere NEMAX-hirsche wenigstens eine kleine portion abschneiden. werde mir die entwicklung ansehen...
      Avatar
      schrieb am 21.07.00 18:31:51
      Beitrag Nr. 7 ()
      ... na das ist doch ein Grund einzusteigen...

      Noch was: Ganz geringes Handelsvolumen an der NASDAQ! Wenn da mal ne Hammermeldung kommt, springt der Umsatz (aktuell 16.000 Stk) rasant an und der Kurs ist kaum zu halten und wir werden alte Höhen wiedersehen ($ 12)!!!

      :) :) :) :)
      Avatar
      schrieb am 24.07.00 17:18:37
      Beitrag Nr. 8 ()
      --> heute der Kurs an der NASDAQ: +13,7% bei einem riesen Umsatz von rund 30.000 Stk!
      Wenn die Umsatz entwicklung heute noch so weiter geht, dann möchte ich nicht wissen wo wir heute abend stehen!
      ==> Dausend! :) :)

      Grüße
      Avatar
      schrieb am 24.07.00 22:25:02
      Beitrag Nr. 9 ()
      Hallo Caly Fans und Normi 2000 ,

      bin auch stark in Caly investiert und glaube das , daß ein sehr seriöses Unternehmen ist .
      Die nächsten Quartalszahlen werden es in sich haben > 5 Mio .
      HIV Urin Tests nach China , Südafrika , Südamerika etc.....

      KZ in der nächsten Zeit 10 bis 15 EURO

      Gruß

      Vince
      Avatar
      schrieb am 25.07.00 08:30:09
      Beitrag Nr. 10 ()
      moin zusammen ,... :)

      das war der Schluß an der Nasdaq ,. nicht schlecht und mal sehen was noch so alles passiert. :)

      MfG

      Last Sale Net Change %Change Share Volume
      $ 2.5313 0.25 10.96% 147,000
      Avatar
      schrieb am 25.07.00 09:49:16
      Beitrag Nr. 11 ()
      ,.... zum 2.ten mal heute morgen :)

      habe jetzt mal intensiv die Umsätze der letzten tage an den hiesigen Börsenplätzen recherchiert ,.... bin wohl der einzigste der in diesen Wert investiert. Trotz guter Vorgaben aus den Staaten besteht an diesem Wert nicht das meiste Interesse. Leider. :(

      Na ja , kommt ja vielleicht noch ,.... irgendwann :rolleyes:

      MfG :):):)
      Avatar
      schrieb am 25.07.00 16:29:04
      Beitrag Nr. 12 ()
      ... stimmt! Wir müssen die Leute hierzu Lande auf diesen Titel aufmerksam machen!
      Vielleicht schreibt ja mal einer zu Förtschi (*g*), der wird ihn uns bestimmt hochpuschen....

      heute: trotz NASDAQ und Biotechschwäche ein Plus von 1,23%!!!!


      Ciao
      normi
      Avatar
      schrieb am 25.07.00 17:07:22
      Beitrag Nr. 13 ()
      @Normi

      der aktuelle stand ist leider nicht + % sondern 3,71% minus bei einem Volumen von 17.000 Stück. Nu ja , gestern war es ja nicht anders , im Verlauf hat der Wert sich gesteigert. :)

      MfG
      Avatar
      schrieb am 25.07.00 18:10:35
      Beitrag Nr. 14 ()
      Ja, er war aber im Plus...

      Und nun? Jetzt ist er auf einmal 11,11 % im Minus (Hilfe!!) bei einem Umsatz von 28.600!

      Aber gestern, war es nicht so wie heute! Gestern den ganzen Tag zw. +13% bis +16% und am Ende stand der kurs dann bei +10%!

      Aber ich hoff der Kurs erholt sich wieder ein bißchen! Wenn da ein 1000er Auftrag kommt ist die Hälfte der Verluste wieder weg! Das passiert eben, bei so geringen Umsätzen!

      Grüße
      normi
      Avatar
      schrieb am 25.07.00 21:47:08
      !
      Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an feedback@wallstreet-online.de
      Avatar
      schrieb am 28.07.00 16:31:57
      Beitrag Nr. 16 ()
      hallo zusammen :)

      nur zur Info , das ist stand der Dinge z.Zt.

      MfG :):):)

      CALY Calypte Biomedical Corporation CALY
      Last Sale: $ 2.4688 Net Change: 0.0938
      Today`s High: $ 2.5 Today`s Low: $ 2.2813
      Best Bid: $ 2.4063 Best Ask: $ 2.4688
      Volume: 8,400 Previous Close: $ 2.375
      Avatar
      schrieb am 25.08.00 16:03:04
      Beitrag Nr. 17 ()
      ja leute, heute is das passiert, was ich euch immer vorraus gesagt habe :)

      an der Nasdaq: calypte Bio. +225%!! bei einem wahnsinnsumsatz ..
      mal sehen was drauß wird ..

      weiß jm warum heute dieser starke anstieg? bitte posten ...

      danke
      normi
      Avatar
      schrieb am 25.08.00 16:10:57
      Beitrag Nr. 18 ()
      Bis gestern NULL Umsatz!!!!!


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