Columbia Labs ++REBOUND++ - 500 Beiträge pro Seite
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Meistdiskutierte Wertpapiere
Platz | vorher | Wertpapier | Kurs | Perf. % | Anzahl | ||
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1. | 1. | 0,1885 | -0,26 | 63 | |||
2. | 2. | 1,1800 | -14,49 | 55 | |||
3. | 3. | 18.188,00 | -0,01 | 46 | |||
4. | 4. | 2.335,99 | -0,08 | 38 | |||
5. | 5. | 168,29 | -1,11 | 22 | |||
6. | 6. | 7,3500 | +3,81 | 14 | |||
7. | 8. | 63.109,33 | -0,75 | 12 | |||
8. | 7. | 6,7910 | 0,00 | 12 |
Für mich klare Panikverkäufe und zu heftiger Absturz
nach folgender Meldung:
BOSTON (MarketWatch) --
Shares of Columbia Laboratories CBRX -55.78% plunged nearly 60% to 65 cents on Monday.
Late Friday, an advisory panel of the U.S. Food and Drug Administration voted against recommending approval of the company's progesterone gel to help prevent premature deliveries in pregnant women with short cervixes, citing insufficient data. While the agency is not bound to the recommendations of its panels, it generally follows them. The product, which is co-marketed by Watson Pharmaceuticals -2.06% , is already on the market to treat progesterone deficiencies in women undergoing certain fertility treatments. The FDA is expected to make a final decision by Feb. 26.
Was meint ihr?
nach folgender Meldung:
BOSTON (MarketWatch) --
Shares of Columbia Laboratories CBRX -55.78% plunged nearly 60% to 65 cents on Monday.
Late Friday, an advisory panel of the U.S. Food and Drug Administration voted against recommending approval of the company's progesterone gel to help prevent premature deliveries in pregnant women with short cervixes, citing insufficient data. While the agency is not bound to the recommendations of its panels, it generally follows them. The product, which is co-marketed by Watson Pharmaceuticals -2.06% , is already on the market to treat progesterone deficiencies in women undergoing certain fertility treatments. The FDA is expected to make a final decision by Feb. 26.
Was meint ihr?
sieht interessant aus - wie ist die restliche pipeline?
Es scheint mal wieder so, dass die Anwälte dick Geld verdienen wollen.
"The Law Firm of Levi & Korsinsky Notifies Investors with Losses on Their Investment in Columbia Laboratories Inc. of Class Action Lawsuit and the Deadline of April 2, 2012 to Seek a Lead Plaintiff Position"
Exkurs:
Aber ist es nicht so, jeder der in Biotech Sektor investiert spekulativ unterwegs ist und vieles auch bewertungstechnisch irrational ist,
siehe Savient Pharmaceutical Aktienkurs,notiert auf roundabout Allzeittief,trotz, dass sie zwei Produkte am Ende geschaffen haben Krystexxa & Oxandrin. Vielleicht liegt es aber auch an der Wirksamkeit von Krystexxa und das noch kein Auffkäufer existiert.
Meiner Meinung kann man auch hier nur long sein!
Columbia Labs:
die Pipeline von Columbia Labs ist bescheiden, aber für mich dennoch ein spekulativer Kaufkandidat, wegen noch ausstehender Entscheidung oder Übernahme (Watson) etc. pp.
Quelle:http://www.columbialabs.com/r-d-overview.htm
Chart:
pro: keine Splits,schön volatiler Chart seit 1988
"The Law Firm of Levi & Korsinsky Notifies Investors with Losses on Their Investment in Columbia Laboratories Inc. of Class Action Lawsuit and the Deadline of April 2, 2012 to Seek a Lead Plaintiff Position"
Exkurs:
Aber ist es nicht so, jeder der in Biotech Sektor investiert spekulativ unterwegs ist und vieles auch bewertungstechnisch irrational ist,
siehe Savient Pharmaceutical Aktienkurs,notiert auf roundabout Allzeittief,trotz, dass sie zwei Produkte am Ende geschaffen haben Krystexxa & Oxandrin. Vielleicht liegt es aber auch an der Wirksamkeit von Krystexxa und das noch kein Auffkäufer existiert.
Meiner Meinung kann man auch hier nur long sein!
Columbia Labs:
die Pipeline von Columbia Labs ist bescheiden, aber für mich dennoch ein spekulativer Kaufkandidat, wegen noch ausstehender Entscheidung oder Übernahme (Watson) etc. pp.
Quelle:http://www.columbialabs.com/r-d-overview.htm
Chart:
pro: keine Splits,schön volatiler Chart seit 1988
Antwort auf Beitrag Nr.: 42.691.894 von sebirem am 03.02.12 08:17:14Hi,
stimem dir zu. Besonders der Chart macht mir Mut. Außerdem hat man ja schon Produkte auf dem Markt und verdient Geld. Bei Sharewise gibt es auch Empfehlungen von Top Usern.
Bist du schon long?
stimem dir zu. Besonders der Chart macht mir Mut. Außerdem hat man ja schon Produkte auf dem Markt und verdient Geld. Bei Sharewise gibt es auch Empfehlungen von Top Usern.
Bist du schon long?
jetzt kommt volumen in die sache!!
Antwort auf Beitrag Nr.: 42.714.702 von misterwrong am 07.02.12 19:37:14war ja heute mal ein anfang - ist aber erst der anfang
Antwort auf Beitrag Nr.: 42.757.813 von Gustl24 am 15.02.12 23:03:23das denke ich auch. welche kursziele siehst du kurzfristig?
was für ein finish! das kann nur ein dicker investor bringen was da gekauft wurde...
kursziel 2$ wenn FDA mitspielt ende nächster woche...evtl. bis ende febr.
bleibt der pre-m geschlossen wenn kein umsatz da ist?
meinst du den us pre-market?
weiss ich nicht, aber was willst du mit dem pre-market?
nächste woche wird es hier lustig!
nächste woche wird es hier lustig!
No Pre-Market trades have been reported for this security.
und das um 15:00h bedeutet doch kein umsatz, oder???
und das um 15:00h bedeutet doch kein umsatz, oder???
mal ein beitrag aus dem us-board iHub von
letztem freitag mit etwas "substanz" und
mit medizinischem hintergrund ohne dem normalen "marktgeschrei"...
so schlecht sind die ergebnisse nicht...:
Just reread the text of the AD-OP on FDA website and you will be grabbing this with three hands. The issue being addressed by WPI is not whether "Progestrone Gel" is statistically signifant versus placebo. No, the beef was only in the method used by CBRX in analyzing the results. WHile CBRX "pooled" the results, FDA analyst reviewed the results by region. In non US regions - Prochieve was statistically significant. In fact, In South Africa and Belarus, not s single preterm was recorded in women using progestrone gel while preterm birth levels on subjects on placebo was disturbing. Here's an exerpt "South Africa (with 11 placebo subjects and 10 progesterone gel subjects) and Belarus (with six placebo subjects and five progesterone gel subjects) had very high rates of preterm birth in the placebo subjects, and no preterm births at = 32 6/7 weeks among progesterone gel-treated subjects. This resulted in a large treatment effect favoring progesterone gel in these countries."
Even results from India and Ukraine supports statistical significance "In contrast, preterm delivery rates among placebo subjects in India and Ukraine are very low, but still 4-8% higher than those among progesterone gel-treated subjects."
Also, by race, Prochieve was statistically significant "Overall, there was minimal efficacy in Asian subjects, possibly because the background rate of prematurity was quite low.
Efficacy in Caucasians and Blacks favored progesterone gel. In Caucasians, the treatment benefit was greatest in the earlier gestational ages, while in Blacks, efficacy increased as gestational age advanced."
The US result is not reliable because there was heavy non-compliance. Of course, US preterm background was also a noted variable. And when you consider that incidences of preterm would be diminished in the US because of superior medical systems vs the five other countries in the trial, you'd be loading up as I have on the stock. The FDA reviewer needed additional data since, according to him, the USresult of the "single" study did not make the overal result to be of "highly persuasive significance." Hence additional data is needed.
And, as I have always stated, the stock is already dirty cheap on its own. When you add the Perceived Future Value of Prochieve being approved, you see a multi-badger! Don't forget the short numbers. I am sure most of you are in already.
letztem freitag mit etwas "substanz" und
mit medizinischem hintergrund ohne dem normalen "marktgeschrei"...
so schlecht sind die ergebnisse nicht...:
Just reread the text of the AD-OP on FDA website and you will be grabbing this with three hands. The issue being addressed by WPI is not whether "Progestrone Gel" is statistically signifant versus placebo. No, the beef was only in the method used by CBRX in analyzing the results. WHile CBRX "pooled" the results, FDA analyst reviewed the results by region. In non US regions - Prochieve was statistically significant. In fact, In South Africa and Belarus, not s single preterm was recorded in women using progestrone gel while preterm birth levels on subjects on placebo was disturbing. Here's an exerpt "South Africa (with 11 placebo subjects and 10 progesterone gel subjects) and Belarus (with six placebo subjects and five progesterone gel subjects) had very high rates of preterm birth in the placebo subjects, and no preterm births at = 32 6/7 weeks among progesterone gel-treated subjects. This resulted in a large treatment effect favoring progesterone gel in these countries."
Even results from India and Ukraine supports statistical significance "In contrast, preterm delivery rates among placebo subjects in India and Ukraine are very low, but still 4-8% higher than those among progesterone gel-treated subjects."
Also, by race, Prochieve was statistically significant "Overall, there was minimal efficacy in Asian subjects, possibly because the background rate of prematurity was quite low.
Efficacy in Caucasians and Blacks favored progesterone gel. In Caucasians, the treatment benefit was greatest in the earlier gestational ages, while in Blacks, efficacy increased as gestational age advanced."
The US result is not reliable because there was heavy non-compliance. Of course, US preterm background was also a noted variable. And when you consider that incidences of preterm would be diminished in the US because of superior medical systems vs the five other countries in the trial, you'd be loading up as I have on the stock. The FDA reviewer needed additional data since, according to him, the USresult of the "single" study did not make the overal result to be of "highly persuasive significance." Hence additional data is needed.
And, as I have always stated, the stock is already dirty cheap on its own. When you add the Perceived Future Value of Prochieve being approved, you see a multi-badger! Don't forget the short numbers. I am sure most of you are in already.
quelle aus usa kurz nach dem "absturz" im januar 2012...
zeigt aber sehr gut die aktuelle "problematik":
Setback for Colombia Laboratories (NASDAQ: CBRX) May be Perfect Opportunity for Investors to Capitalize
Posted on January 26, 2012 Quelle: OTCEquity
After being dealt a significant setback last Friday following a negative vote by the FDA Advisory Committee regarding their progesterone vaginal gel 8%, Prochieve, Colombia Laboratories (NASDAQ: CBRX) is doing everything it can to reassure investors that the game isn’t over just yet. While shares essentially collapsed, falling from a 1.58 close on Friday, trading had been suspended prior to the announcement, down to 0.64 on Monday, there has been a slight rebound as the week has progressed and shares are currently trading around the 0.84 – 0.88 range.
According to the recommendation of the FDA’s Division of Reproductive and Urologic Products the company failed to show statistically significant efficacy in reducing the risk of pre-term birth in women with a single gestation and a short uterine cervical length at the mid-trimester of pregnancy. Despite the negative 13-4 recommendation handed down by the FDA Advisory Committee Frank Condella, President and CEO of CBRX, said “We will work with the FDA to address the Advisory Committee’s comments as the Agency finalizes its review of our NDA. We remain confident in the PREGNANT study results that showed the administration of progesterone vaginal gel 8% is a safe and effective treatment for patients at risk for preterm birth due to short uterine cervical length in the mid-trimester of pregnancy. We hope the agency’s final decision will acknowledge the clear unmet medical need in this patient population.”
That final decision is slated for on or before February 26, 2012 and while the overwhelming majority of investors anticipate a negative outcome that doesn’t necessarily shut the door on Prochieve’s future. In all likelihood CBRX will be issued a Complete Response Letter from the FDA outlining the need for additional trials that will address some of the deficiencies that exist with their current results.
Those deficiencies are essentially based on the results which showed the Prochieve’s efficacy was nearly identical to placebo in female patients in the United States. Interestingly, CBRX had published information touting positive results but those results were based on clinical studies conducted outside of the U.S....
zeigt aber sehr gut die aktuelle "problematik":
Setback for Colombia Laboratories (NASDAQ: CBRX) May be Perfect Opportunity for Investors to Capitalize
Posted on January 26, 2012 Quelle: OTCEquity
After being dealt a significant setback last Friday following a negative vote by the FDA Advisory Committee regarding their progesterone vaginal gel 8%, Prochieve, Colombia Laboratories (NASDAQ: CBRX) is doing everything it can to reassure investors that the game isn’t over just yet. While shares essentially collapsed, falling from a 1.58 close on Friday, trading had been suspended prior to the announcement, down to 0.64 on Monday, there has been a slight rebound as the week has progressed and shares are currently trading around the 0.84 – 0.88 range.
According to the recommendation of the FDA’s Division of Reproductive and Urologic Products the company failed to show statistically significant efficacy in reducing the risk of pre-term birth in women with a single gestation and a short uterine cervical length at the mid-trimester of pregnancy. Despite the negative 13-4 recommendation handed down by the FDA Advisory Committee Frank Condella, President and CEO of CBRX, said “We will work with the FDA to address the Advisory Committee’s comments as the Agency finalizes its review of our NDA. We remain confident in the PREGNANT study results that showed the administration of progesterone vaginal gel 8% is a safe and effective treatment for patients at risk for preterm birth due to short uterine cervical length in the mid-trimester of pregnancy. We hope the agency’s final decision will acknowledge the clear unmet medical need in this patient population.”
That final decision is slated for on or before February 26, 2012 and while the overwhelming majority of investors anticipate a negative outcome that doesn’t necessarily shut the door on Prochieve’s future. In all likelihood CBRX will be issued a Complete Response Letter from the FDA outlining the need for additional trials that will address some of the deficiencies that exist with their current results.
Those deficiencies are essentially based on the results which showed the Prochieve’s efficacy was nearly identical to placebo in female patients in the United States. Interestingly, CBRX had published information touting positive results but those results were based on clinical studies conducted outside of the U.S....
Antwort auf Beitrag Nr.: 42.780.221 von Gustl24 am 21.02.12 04:59:40man kann es rel. leicht zusammenfassen:
das leading produkt Prochieve hat vom FDA advisory committee
eine negative 13-4 empfehlung als bewertung bekommen...
FDA final decision termin um Feb.26 mit geringen chancen, da FDA
"häufig" die empfehlungen des committee´s folgt...:
aber:
das produkt ist sicher und das problem liegt "nur" in der stat. signifikanz
der studienergebnisse der "teilgruppe" der us-patientinnen...(!)
in der overall gruppe wurde diese stat. signifikanz wie es scheint erzielt...
es gibt sehr wenige vergleichbare präparate auf dem markt:
Vorteil: blockbusterpotential...
Nachteil: FDA ist immer sehr kritisch bei dergleichen approvals...
CBRX hat einen starken partner mit WPI, welcher nun die "gespräche"
mit FDA und weitere studienauswertungen vornimmt !
die auswertungen und besprechungen zwischen WPI und FDA werden
andauern...und sollte am 26 feb. 2012 FDA kein approval aussprechen,
so sehe ich auf 6-monatsfrist eine hohe möglichkeit, dass diese
dann doch noch kommt...
das kursziel dann sehe ich bei 4-5$...we will see
das leading produkt Prochieve hat vom FDA advisory committee
eine negative 13-4 empfehlung als bewertung bekommen...
FDA final decision termin um Feb.26 mit geringen chancen, da FDA
"häufig" die empfehlungen des committee´s folgt...:
aber:
das produkt ist sicher und das problem liegt "nur" in der stat. signifikanz
der studienergebnisse der "teilgruppe" der us-patientinnen...(!)
in der overall gruppe wurde diese stat. signifikanz wie es scheint erzielt...
es gibt sehr wenige vergleichbare präparate auf dem markt:
Vorteil: blockbusterpotential...
Nachteil: FDA ist immer sehr kritisch bei dergleichen approvals...
CBRX hat einen starken partner mit WPI, welcher nun die "gespräche"
mit FDA und weitere studienauswertungen vornimmt !
die auswertungen und besprechungen zwischen WPI und FDA werden
andauern...und sollte am 26 feb. 2012 FDA kein approval aussprechen,
so sehe ich auf 6-monatsfrist eine hohe möglichkeit, dass diese
dann doch noch kommt...
das kursziel dann sehe ich bei 4-5$...we will see
Antwort auf Beitrag Nr.: 42.780.225 von Gustl24 am 21.02.12 05:16:51zocken die amis den kurs pre-FDA noch etwas höher bis
ende dieser woche > 1 dollar oder warten sie ab...
man weiss es nie bei diesen us-biotech-plays, aber ich werde entspannt
abwarten...und beobachten - mein einkauf hier ist abgeschlossen...
ende dieser woche > 1 dollar oder warten sie ab...
man weiss es nie bei diesen us-biotech-plays, aber ich werde entspannt
abwarten...und beobachten - mein einkauf hier ist abgeschlossen...
Antwort auf Beitrag Nr.: 42.780.231 von Gustl24 am 21.02.12 05:24:22dieser artikel von heute bzgl. einer klage fasst die derzeitige situation hier bei CBRX nochmals gut zusammen:
The Shareholders Foundation announces that an investor in shares of Columbia Laboratories Inc. (NASDAQ:CBRX) filed a lawsuit in the U.S. District Court, District of New Jersey against Columbia Laboratories Inc. over alleged Violations of Federal Securities Laws in connection with certain statements concerning Columbia Laboratories’ progesterone vaginal gel.
Investors who purchased shares of Columbia Laboratories Inc. (NASDAQ: CBRX) have certain options and for certain NASDAQ:CRBX stockholders there are strict and short deadlines running. Deadline: April 2, 2012. NASDAQ:CBRX stockholders should contact the Shareholders Foundation at mail(at)shareholdersfoundation.com or call +1(858) 779 – 1554.
According to the complaint the plaintiff alleges on behalf of all persons or entities who purchased Columbia Laboratories Inc. (NASDAQ: CBRX) securities between December 6, 2010 and January 20, 2012, that Columbia Laboratories, Inc and certain of its officers violated the Securities Exchange Act of 1934 by issuing allegedly materially false and misleading statements.
Specficially the plaintiff alleges that Columbia Laboratories, Inc conditioned investors to believe that Columbia Laboratories’ PROCHIEVE progesterone vaginal gel 8% , a gel intended to prevent preterm births in women with short cervices, would receive Food and Drug Administration (“FDA”) approval through a host of statements regarding the safety and efficacy of the product, as well as reportedly positive results from PROCHIEVE’s clinical trials.
On December 14, 2011, Columbia Laboratories Inc announced that a meta-analysis of data from five double-blind, placebo-controlled trials its progesterone gel product “significantly reduces the risk of preterm birth and neonatal morbidity.”
However on January 17, 2012 a report by the Food and Drug Administration staff about Columbia Laboratories progesterone gel to reduce the risk of preterm birth was released. According to the report Columbia Laboratories’ progesterone gel wasn’t effective.
On January 20, 2012, Columbia Laboratories, Inc. (Nasdaq: CBRX), and Watson Pharmaceuticals, Inc. (NYSE: WPI) confirmed that the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Administration (FDA) declined to recommend the approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy. While panel members generally agreed that progesterone vaginal gel 8% is safe, the panel stated that more information is needed to support approval.
Columbia Laboratories, Inc said the final decision regarding the approval of the product rests solely with the FDA and the FDA’s Division of Reproductive and Urologic Products is expected to take action on Columbia’s New Drug Application (NDA) by February 26, 2012.
On the same day a media report cited advisors to U.S. regulators saying Columbia Laboratories Inc. (CBRX) and Watson Pharmaceuticals Inc. (WPI) didn’t provide sufficient data that their progesterone gel reduces the risk of preterm birth.
Columbia Laboratories Inc. (NASDAQ: CBRX) shares declined an additional $0.874 per share or more than 55%, to close at $0.706 per share on January 23, 2012.
Those who purchased shares of Columbia Laboratories Inc. (NASDAQ: CBRX) have certain options and should contact the Shareholders Foundation.
The Shareholders Foundation announces that an investor in shares of Columbia Laboratories Inc. (NASDAQ:CBRX) filed a lawsuit in the U.S. District Court, District of New Jersey against Columbia Laboratories Inc. over alleged Violations of Federal Securities Laws in connection with certain statements concerning Columbia Laboratories’ progesterone vaginal gel.
Investors who purchased shares of Columbia Laboratories Inc. (NASDAQ: CBRX) have certain options and for certain NASDAQ:CRBX stockholders there are strict and short deadlines running. Deadline: April 2, 2012. NASDAQ:CBRX stockholders should contact the Shareholders Foundation at mail(at)shareholdersfoundation.com or call +1(858) 779 – 1554.
According to the complaint the plaintiff alleges on behalf of all persons or entities who purchased Columbia Laboratories Inc. (NASDAQ: CBRX) securities between December 6, 2010 and January 20, 2012, that Columbia Laboratories, Inc and certain of its officers violated the Securities Exchange Act of 1934 by issuing allegedly materially false and misleading statements.
Specficially the plaintiff alleges that Columbia Laboratories, Inc conditioned investors to believe that Columbia Laboratories’ PROCHIEVE progesterone vaginal gel 8% , a gel intended to prevent preterm births in women with short cervices, would receive Food and Drug Administration (“FDA”) approval through a host of statements regarding the safety and efficacy of the product, as well as reportedly positive results from PROCHIEVE’s clinical trials.
On December 14, 2011, Columbia Laboratories Inc announced that a meta-analysis of data from five double-blind, placebo-controlled trials its progesterone gel product “significantly reduces the risk of preterm birth and neonatal morbidity.”
However on January 17, 2012 a report by the Food and Drug Administration staff about Columbia Laboratories progesterone gel to reduce the risk of preterm birth was released. According to the report Columbia Laboratories’ progesterone gel wasn’t effective.
On January 20, 2012, Columbia Laboratories, Inc. (Nasdaq: CBRX), and Watson Pharmaceuticals, Inc. (NYSE: WPI) confirmed that the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Administration (FDA) declined to recommend the approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy. While panel members generally agreed that progesterone vaginal gel 8% is safe, the panel stated that more information is needed to support approval.
Columbia Laboratories, Inc said the final decision regarding the approval of the product rests solely with the FDA and the FDA’s Division of Reproductive and Urologic Products is expected to take action on Columbia’s New Drug Application (NDA) by February 26, 2012.
On the same day a media report cited advisors to U.S. regulators saying Columbia Laboratories Inc. (CBRX) and Watson Pharmaceuticals Inc. (WPI) didn’t provide sufficient data that their progesterone gel reduces the risk of preterm birth.
Columbia Laboratories Inc. (NASDAQ: CBRX) shares declined an additional $0.874 per share or more than 55%, to close at $0.706 per share on January 23, 2012.
Those who purchased shares of Columbia Laboratories Inc. (NASDAQ: CBRX) have certain options and should contact the Shareholders Foundation.
Antwort auf Beitrag Nr.: 42.787.108 von Gustl24 am 22.02.12 10:03:40wie stark ist die verhandlungsposition von WPI mit FDA...?
das derzeitige "konkurrenzprodukt" unter dem namen Makena ist ebenfalls
umstritten...hat aber vor ca. einem jahr mit auflagen ein approval bekommen...
hier haben wir ein "sicheres" produkt - von FDA bestätigt- mit der frage
der stat. signifikanz der wirkung bzgl. einer "untergruppe" in den pIII
studien - overall war es "stat. signifikant" wirksam...!
sehr spannend...
das derzeitige "konkurrenzprodukt" unter dem namen Makena ist ebenfalls
umstritten...hat aber vor ca. einem jahr mit auflagen ein approval bekommen...
hier haben wir ein "sicheres" produkt - von FDA bestätigt- mit der frage
der stat. signifikanz der wirkung bzgl. einer "untergruppe" in den pIII
studien - overall war es "stat. signifikant" wirksam...!
sehr spannend...
viele gehen von einem nicht-apprival bei progesterone vaginal gel 8%, Prochieve aus, da negativer committee entscheid
-> aber die FDA ist insb.
zur zeit für überraschende entscheidungen auch gut...siehe heute bei
chelsea therap....vor 1 WOCHE noch ablehnend und dann heute das...:
(Reuters)Today - Shares of Chelsea Therapeutics International Ltd (CHTP.O) rose as much as 76 percent on Friday after a committee of independent experts recommended the approval of its hypotension drug in the United States.
The FDA panel voted 7 to 4 in favor of the drug's approval on Thursday. Its recommendation will now be taken into consideration by the FDA, which is expected to make a decision on the drug by March 28.
Wedbush Securities analyst Liana Moussatos said she sees more than an even chance of the drug being approved by the action date, and the company's stock price at least doubling if the approval comes through.
Last week, the company received briefing documents from the U.S. Food and Drug Administration raising questions related to the short duration of clinical studies and the limited size of the study population given the orphan status that the drug, Northera, has.
macht zumindest etwas mut bei CBRX...da die stimmung doch recht skeptisch...
we will see
-> aber die FDA ist insb.
zur zeit für überraschende entscheidungen auch gut...siehe heute bei
chelsea therap....vor 1 WOCHE noch ablehnend und dann heute das...:
(Reuters)Today - Shares of Chelsea Therapeutics International Ltd (CHTP.O) rose as much as 76 percent on Friday after a committee of independent experts recommended the approval of its hypotension drug in the United States.
The FDA panel voted 7 to 4 in favor of the drug's approval on Thursday. Its recommendation will now be taken into consideration by the FDA, which is expected to make a decision on the drug by March 28.
Wedbush Securities analyst Liana Moussatos said she sees more than an even chance of the drug being approved by the action date, and the company's stock price at least doubling if the approval comes through.
Last week, the company received briefing documents from the U.S. Food and Drug Administration raising questions related to the short duration of clinical studies and the limited size of the study population given the orphan status that the drug, Northera, has.
macht zumindest etwas mut bei CBRX...da die stimmung doch recht skeptisch...
we will see
FDA ist gut drauf in letzter Zeit wie man so mitbekommt. Ich bin und bleibe hier long bis wir wieder bei 1,20€ mindestens sind. Der Langzeitchart reicht mir schon.
Antwort auf Beitrag Nr.: 42.803.566 von Gustl24 am 24.02.12 17:15:10weiterer lesestoff aus MEDCITY-news von gestern:
die entscheidung naht...
FDA decision on preterm birth gel closely watched by device-maker Cervilenz
The U.S. Food and Drug Administration is soon expected to decide whether to approve a progesterone vaginal gel that could reduce preterm birth in women.
Cleveland-area CerviLenz, which makes a device to measure the length of a woman’s cervix, is closely watching the FDA’s decision. Approval of the drug, Prochieve 8%, could speed adoption of CerviLenz’s device, because the device could be used as a screening tool to identify candidates for the drug. A short cervix is the best predictor of preterm birth risk.
Prochieve 8% has what’s known as a PDUFA date on Sunday, Feb. 26. Essentially, that’s the day by which the FDA is expected to announce its ruling on whether the drug has been approved, but the FDA isn’t bound by the date. It could announce a decision as soon as today or, more likely, later next week.
Last month, an FDA panel voted 13-4 against approving the progesterone-based gel, which was developed by Columbia Laboratories’ (NASDAQ:CBRX) and Watson Pharmaceuticals’ (NYSE:WPI).
The panel said the drug’s single trial did not show a statistically significant reduction in preterm birth among U.S. women. However, data from the phase 3 clinical trial showed the drug was associated with a 45 percent reduction in preterm births in pregnant women with a short cervix — but that data includes both U.S. and international study participants.
Die alles entscheidente Frage: Overall oder Gruppe der US-Frauen -
was wird die FDA entscheiden !!!!
While that may not augur well for the drug’s approval, it’s important to note that the FDA is not bound by decisions by its panels and occasionally issues a decision counter to a panel’s recommendation.
Preterm births have been on the rise for the past 20 years in the United States and account for about 12 percent of births, according to the Centers of Disease Control and Prevention. Although KV Pharmaceuticals’ Makena was approved nearly two years ago for preterm birth in women with a history of the condition, Prochieve 8% is for women with a short cervix.
As standard clinical practice moves more toward screening all women to reduce the prevalence of preterm birth, it could hold big things for CerviLenz and the company’s simple, low-cost device.
A study published in the February 2012 issue of the American Journal of Obstetrics and Gynecology recommended cervical length measurement of all pregnant women at between 19 and 24 weeks of gestation.
The other method for measuring cervical length, vaginal ultrasound, isn’t used for all pregnant women, in part because it’s generally too expensive and time-consuming to be done multiple times for one pregnancy.
In a 2006 report, the Institute of Medicine said preterm births cost the U.S. $26 billion per year.
die entscheidung naht...
FDA decision on preterm birth gel closely watched by device-maker Cervilenz
The U.S. Food and Drug Administration is soon expected to decide whether to approve a progesterone vaginal gel that could reduce preterm birth in women.
Cleveland-area CerviLenz, which makes a device to measure the length of a woman’s cervix, is closely watching the FDA’s decision. Approval of the drug, Prochieve 8%, could speed adoption of CerviLenz’s device, because the device could be used as a screening tool to identify candidates for the drug. A short cervix is the best predictor of preterm birth risk.
Prochieve 8% has what’s known as a PDUFA date on Sunday, Feb. 26. Essentially, that’s the day by which the FDA is expected to announce its ruling on whether the drug has been approved, but the FDA isn’t bound by the date. It could announce a decision as soon as today or, more likely, later next week.
Last month, an FDA panel voted 13-4 against approving the progesterone-based gel, which was developed by Columbia Laboratories’ (NASDAQ:CBRX) and Watson Pharmaceuticals’ (NYSE:WPI).
The panel said the drug’s single trial did not show a statistically significant reduction in preterm birth among U.S. women. However, data from the phase 3 clinical trial showed the drug was associated with a 45 percent reduction in preterm births in pregnant women with a short cervix — but that data includes both U.S. and international study participants.
Die alles entscheidente Frage: Overall oder Gruppe der US-Frauen -
was wird die FDA entscheiden !!!!
While that may not augur well for the drug’s approval, it’s important to note that the FDA is not bound by decisions by its panels and occasionally issues a decision counter to a panel’s recommendation.
Preterm births have been on the rise for the past 20 years in the United States and account for about 12 percent of births, according to the Centers of Disease Control and Prevention. Although KV Pharmaceuticals’ Makena was approved nearly two years ago for preterm birth in women with a history of the condition, Prochieve 8% is for women with a short cervix.
As standard clinical practice moves more toward screening all women to reduce the prevalence of preterm birth, it could hold big things for CerviLenz and the company’s simple, low-cost device.
A study published in the February 2012 issue of the American Journal of Obstetrics and Gynecology recommended cervical length measurement of all pregnant women at between 19 and 24 weeks of gestation.
The other method for measuring cervical length, vaginal ultrasound, isn’t used for all pregnant women, in part because it’s generally too expensive and time-consuming to be done multiple times for one pregnancy.
In a 2006 report, the Institute of Medicine said preterm births cost the U.S. $26 billion per year.
Antwort auf Beitrag Nr.: 42.806.215 von Gustl24 am 25.02.12 11:02:05wie ich gerade sehe hat einer kurz vor börsenschluss in FFM
gestern noch mit 1000 stücken ne kurze "zockerkarte" zu 75 cent für
FDA-entscheid übers wochenende gelöst...gut
wenn negativer beschluss vielleicht 2-300 euro verlust (wenn realisiert)
wenn positiver beschluss locker 1000 euro gewinn schätz ich mal...
mein einsatz ist deutlich höher...ich werde aber auch long bleiben...
für mich ist vorerst, je nach beschlussfassung, am 26.02.2012 nur
zwischenstation...so jetzt warten wir mal und hoffen...
ein schönes wochenende allen...
gestern noch mit 1000 stücken ne kurze "zockerkarte" zu 75 cent für
FDA-entscheid übers wochenende gelöst...gut
wenn negativer beschluss vielleicht 2-300 euro verlust (wenn realisiert)
wenn positiver beschluss locker 1000 euro gewinn schätz ich mal...
mein einsatz ist deutlich höher...ich werde aber auch long bleiben...
für mich ist vorerst, je nach beschlussfassung, am 26.02.2012 nur
zwischenstation...so jetzt warten wir mal und hoffen...
ein schönes wochenende allen...
für ein approval brauchen wir schon ein mittleres wunder - bin gespannt
Antwort auf Beitrag Nr.: 42.808.040 von misterwrong am 26.02.12 10:13:57wunder nicht eingetreten...:
Watson Pharmaceuticals, Inc. (NYSE: WPI) and Columbia Laboratories, Inc. (Nasdaq: CBRX) today confirmed that, as expected, Watson has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA 22-139) for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy.
The complete response letter stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of preterm birth in women with a short uterine cervical length at </= 32 6/7 weeks gestation (p=0.022) did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial. Although not part of the requirements communicated to the sponsor during pre-Phase III meetings, the FDA also raised the issue of robustness in efficacy in the U.S. sub-cohort as compared to the overall efficacy of the trial. In the complete response letter, FDA stated that additional clinical work would be required to support the approval.
die amis sehen es z.t. doch noch recht positiv...mal schauen, was der markt
draus macht...abstufung war ja:
approval - CRL - ablehnung...jetzt stehen wir in der mitte...
Watson Pharmaceuticals, Inc. (NYSE: WPI) and Columbia Laboratories, Inc. (Nasdaq: CBRX) today confirmed that, as expected, Watson has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA 22-139) for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy.
The complete response letter stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of preterm birth in women with a short uterine cervical length at </= 32 6/7 weeks gestation (p=0.022) did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial. Although not part of the requirements communicated to the sponsor during pre-Phase III meetings, the FDA also raised the issue of robustness in efficacy in the U.S. sub-cohort as compared to the overall efficacy of the trial. In the complete response letter, FDA stated that additional clinical work would be required to support the approval.
die amis sehen es z.t. doch noch recht positiv...mal schauen, was der markt
draus macht...abstufung war ja:
approval - CRL - ablehnung...jetzt stehen wir in der mitte...
unterstützung bei 0.67 $ ist da - das dürfte der Boden sein.