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DISCOVERY LABORATORIES // Chance auf Zulassung?
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NASDAQ Last Sale
1.69 0.58 52.25%
Volume
16,553 Previous Close
$ 1.11
Today's High
$ 2.00 Today's Low
$ 1.57
1.69 0.58 52.25%
Volume
16,553 Previous Close
$ 1.11
Today's High
$ 2.00 Today's Low
$ 1.57
hast recht, da wird aufmagaziniert.....
lg
auf der Wachtlist habe ich sie schon!
lg
auf der Wachtlist habe ich sie schon!
DOW JONES NEWSWIRES
Discovery Laboratories Inc. (DSCO) is optimistic it will be able to assuage Food and Drug Administration concerns about a quality-control test for its lead drug.
Shares soared 76% premarket to $1.95. The stock tumbled to an all-time low of 33 cents in July after the small drug developer said it looked increasingly unlikely Surfaxin would get near-term approval.
At the time, Discovery said the FDA would apply a new standard in determining the comparability of Surfaxin in its clinical form to the commercial version that Discovery has manufactured. The FDA also suggested an additional limited trial on the drug, which treats a breathing problem in premature babies.
The company said Wednesday it believes it has "reached an understanding" with the FDA about a quality-control stability release test for Surfaxin. The company said it received agency guidance regarding design of the drug's final trial. Discovery hopes to submit a plan in November.
The issue at hand developed after Discovery conducted Phase 3 trials that employed "an array of quality control tests," but not the one being discussed with the FDA.
-By Kevin Kingsbury, Dow Jones Newswires; 212-416-2354; kevin.kingsbury@ dowjones.com
(END) Dow Jones Newswires
09-30-090732ET
Discovery Laboratories Inc. (DSCO) is optimistic it will be able to assuage Food and Drug Administration concerns about a quality-control test for its lead drug.
Shares soared 76% premarket to $1.95. The stock tumbled to an all-time low of 33 cents in July after the small drug developer said it looked increasingly unlikely Surfaxin would get near-term approval.
At the time, Discovery said the FDA would apply a new standard in determining the comparability of Surfaxin in its clinical form to the commercial version that Discovery has manufactured. The FDA also suggested an additional limited trial on the drug, which treats a breathing problem in premature babies.
The company said Wednesday it believes it has "reached an understanding" with the FDA about a quality-control stability release test for Surfaxin. The company said it received agency guidance regarding design of the drug's final trial. Discovery hopes to submit a plan in November.
The issue at hand developed after Discovery conducted Phase 3 trials that employed "an array of quality control tests," but not the one being discussed with the FDA.
-By Kevin Kingsbury, Dow Jones Newswires; 212-416-2354; kevin.kingsbury@ dowjones.com
(END) Dow Jones Newswires
09-30-090732ET
9/30/2009 7:52:59 AM Market Closed
NASDAQ Last Sale
1.64 0.53 47.75%
Volume
37,253 Previous Close
$ 1.11
Today's High
$ 2.00 Today's Low
$ 1.55
NASDAQ Last Sale
1.64 0.53 47.75%
Volume
37,253 Previous Close
$ 1.11
Today's High
$ 2.00 Today's Low
$ 1.55
15:17:23 1,20 6.000
15:14:37 1,20 625
14:44:46 1,15 1.500
14:06:04 0,90 2.800
15:14:37 1,20 625
14:44:46 1,15 1.500
14:06:04 0,90 2.800
musst Dich durchlesen
www.boardcentral.com/boards/DSCO
www.boardcentral.com/boards/DSCO
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TOPIC: Discovery Labs: Pump Up the Volume
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1 Hour, 4 Minutes ago #46
Discovery Labs: Pump Up the Volume
WARRINGTON, Pa. (TheStreet) -- Discovery Laboratories (DSCO Quote) shares were sliding on above-average volume Friday, giving back gains earned earlier in the week on positive news for its experimental lung drug.
Discovery Labs announced that the FDA deemed "reasonable" its proposed program to improve testing for Surfaxin, a drug aimed at treating respiratory distress syndrome in premature infants. Discovery Labs also received guidance from the FDA on its proposed limited clinical trial design. The FDA regulatory process has led to long delays for Surfaxin. The meeting with the FDA this week focused on Discovery Labs' plans regarding optimization and final method validation of its Biological Activity Test, or BAT, and a proposed limited Surfaxin clinical trial design, which would simultaneously employ the newly optimized BAT, the company said.
Discovery Labs shares jumped 22.5% Wednesday before retreating 11% Thursday. Lately, the stock was down 12 cents, or 9.9%, to $1.09. Earlier, the stock touched an intraday high of $1.03.
More than 8 million shares changed hands by 12:25 p.m. EDT Friday, not far off the stock's 50-day average daily volume of 8.1 million, according to the Nasdaq's Web site.
Discovery Labs had a 115.2 million-share float with a short interest float of 10.8% as of Sept. 10, according to Yahoo! Finance. Only 5.5% of the company's shares are held by insiders, with another 36.7% owned by institutions.
Investor posts on Internet message boards Friday argued that there is plenty of risk in Discovery shares and that they are not a long-term hold. Others argued that the stock was an easy target for short traders, because the news earlier this week was that the proposed test was accepted, not that Surfaxin has been approved.
Bullish traders said the pullback in shares offered a more attractive entry point, and others said they were covering their short positions after Friday's decline.
Read more about today's high-volume stocks like EnteroMedics in earlier "Pump Up the Volume" posts.
-- Written by Robert Holmes in New York.
www.thestreet.com/_yahoo/story/10606562/...t=FREE&cm_ite=NA
COMMUNITYGROUPSSTOCK BOARDSCOMPANIESSino Clean EnergyAdamis PharmaceuticalsEcologic TransportationChina Carbon GraphiteChina TelChina Jo-Jo Drugstores
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Reply Topic New thread Page: 1
TOPIC: Discovery Labs: Pump Up the Volume
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Latest posts
1 Hour, 4 Minutes ago #46
Discovery Labs: Pump Up the Volume
WARRINGTON, Pa. (TheStreet) -- Discovery Laboratories (DSCO Quote) shares were sliding on above-average volume Friday, giving back gains earned earlier in the week on positive news for its experimental lung drug.
Discovery Labs announced that the FDA deemed "reasonable" its proposed program to improve testing for Surfaxin, a drug aimed at treating respiratory distress syndrome in premature infants. Discovery Labs also received guidance from the FDA on its proposed limited clinical trial design. The FDA regulatory process has led to long delays for Surfaxin. The meeting with the FDA this week focused on Discovery Labs' plans regarding optimization and final method validation of its Biological Activity Test, or BAT, and a proposed limited Surfaxin clinical trial design, which would simultaneously employ the newly optimized BAT, the company said.
Discovery Labs shares jumped 22.5% Wednesday before retreating 11% Thursday. Lately, the stock was down 12 cents, or 9.9%, to $1.09. Earlier, the stock touched an intraday high of $1.03.
More than 8 million shares changed hands by 12:25 p.m. EDT Friday, not far off the stock's 50-day average daily volume of 8.1 million, according to the Nasdaq's Web site.
Discovery Labs had a 115.2 million-share float with a short interest float of 10.8% as of Sept. 10, according to Yahoo! Finance. Only 5.5% of the company's shares are held by insiders, with another 36.7% owned by institutions.
Investor posts on Internet message boards Friday argued that there is plenty of risk in Discovery shares and that they are not a long-term hold. Others argued that the stock was an easy target for short traders, because the news earlier this week was that the proposed test was accepted, not that Surfaxin has been approved.
Bullish traders said the pullback in shares offered a more attractive entry point, and others said they were covering their short positions after Friday's decline.
Read more about today's high-volume stocks like EnteroMedics in earlier "Pump Up the Volume" posts.
-- Written by Robert Holmes in New York.
www.thestreet.com/_yahoo/story/10606562/...t=FREE&cm_ite=NA
NASDAQ Last Sale
0.70 0.07 11.29%
Volume
1,322,429 Previous Close
$ 0.62
Today's High
$ 1.40 Today's Low
$ 0.62
0.70 0.07 11.29%
Volume
1,322,429 Previous Close
$ 0.62
Today's High
$ 1.40 Today's Low
$ 0.62
wie im lotto alles ist möglich!
kaufe aktien die keiner mehr haben will
und am ende wird alles gut!
kaufe aktien die keiner mehr haben will
und am ende wird alles gut!
16:45 $ 1 1,000
16:45 $ 1.10 900
16:45 $ 1.40 7,200
16:45 $ .69 2,040
16:45 $ 1.40 1,000
16:45 $ 1.40 960
16:45 $ .69 100
16:39 $ .6885 1,800
16:45 $ 1.10 900
16:45 $ 1.40 7,200
16:45 $ .69 2,040
16:45 $ 1.40 1,000
16:45 $ 1.40 960
16:45 $ .69 100
16:39 $ .6885 1,800
wie im lotto alles ist möglich!
kaufe aktien die keiner mehr haben will
und am ende wird alles gut!
kaufe aktien die keiner mehr haben will
und am ende wird alles gut!
Keine Kauf Empfehlung!!
brunneta
brunneta
Discovery steht in den Startlöchern....
könnte sich das mit der Zulassung noch bis März hinziehen. Aber ich weiß nicht genau wie die da arbeiten und ob es trotzdem Zulassungen unabhänhig von den Einzelbesprechungen gibt March * March 1 - Cardiovascular and Renal Drugs Advisory Committee * March 5 - General Hospital and Personal Use Devices Panel * March 9 - Pulmonary-Allergy Drugs Advisory Committee * March 10 - Pulmonary-Allergy Drugs Advisory Committee * March 11-12 - Neurological Devices Panel * March 11-12 - Gastroenterology-Urology Devices Panel * March 15- Microbiology Devices Panel * March 17 - Pharmaceutical Science and Clinical Pharmacology Advisory Committee * March 17-18 - Clinical Chemistry and Clinical Toxicology Devices Panel * March 18-19 - Veterinary Medicine Advisory Committee * March 19 - Microbiology Devices Panel * March 22 - Pediatric Advisory Committee * March 23 - Peripheral and Central Nervous System Drugs Advisory Committee * March 23 - Dental Products Panel * March 23 - Orthopaedic and Rehabilitation Devices Panel * March 24 - Peripheral and Central Nervous System Drugs Advisory Committee * March dates to be announced - Tobacco Products Scientific Advisory Committee
Sobald wieder ein paar Scheinchen frei sind, fahre ich mal ein paar Haltestellen mit :-)
denkt jemand heute kommen news?
Es gibt keine neuen Beiträge.
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