Medigene / Gegenwart und Zukunft (Seite 4423)

[Gustl24]

Antwort auf Beitrag Nr.: 36.982.650 von gnomli am 16.04.09 18:59:15

danke für deine einschätzung - vor allem der punkt
lobby big pharma wird wohl häufig unterschätzt -
sollte approval kommen sicherlich gute chancen
da usa für solche hypes z.zt. sehr empfänglich
siehe dendreon, bankaktien usw....

[Richardundzdf]

heute wurden erneut für 10.000 EUR Optionsscheine gekauft

[gnomli]

Antwort auf Beitrag Nr.: 36.982.513 von Gustl24 am 16.04.09 18:42:50

wie beschrieben, prinzipiell ein bet a la dendreon.
da jedoch nur "stability" und manufacturing betroffen ist sollten sie das loesen koennen - selbst wenn die stabilitaet des produktes nicht gut bei RT ist gibt es da tricks wie z.b. bei formoterolfumarat, (kuehlkette bis zum endverbraucher, doppelte Alu/alu verpackung...)

falls also kein fundamentaeler fehler in der entwicklung vorliegt hast du hier gute Chancen - aber FDA einzuschaetzen ist schwer.
(Eventuell auch durch gute Lobbyarbeit seitens big Pharma manchmal doppelt schwer)

[starwarrior03]

Antwort auf Beitrag Nr.: 36.982.522 von noa235 am 16.04.09 18:43:34

wird alles genau beobachtet... und "push"lig dargestellt..

[noa235]

ups, hab mich wohl verguckt, habt recht.

[Gustl24]

für leute mit extrem hohem risikopotential:
kennt jemand diese firma, hab mich heute mit einer tradingposition
hier im tief eingekauft...morgen fda-entscheidung??

Discovery Labs Awaiting Critical FDA Decision On Surfaxin
Thursday April 16th, 2009 / 16h38



By Jennifer Hoyt Of DOW JONES NEWSWIRES NEW YORK -(Dow Jones)- Discovery Laboratories Inc. (DSCO) is hoping the fourth time is the charm as it awaits a critical FDA decision Friday on the company's lead drug, Surfaxin.
Shares of Discovery had surged in recent weeks in an apparent bet the biotechnology company will finally see a positive end to the more-than-four-year approval process stymieing the drug, which treats a breathing problem in premature infants. But the stock fell sharply Thursday as investors appeared to be getting skittish about the decision.
Shares have more than doubled to around $2.40 from near-record lows in March but are still miles from the near-$12-a-share price they fetched in 2004. In recent trading Thursday, the shares were down 16% to $1.95 on heavy volumes.
Surfaxin's already been before the FDA on three occasions and has been issued an approvable letter each time. These letters mean the FDA may give final approval, but only after evaluating more information.
The fate of the company, which specializes in lung drugs, could now hang in the balance as many of its other products are much fresher in the pipeline, observers said.
The good news for Discovery is that the FDA hasn't been focusing on efficacy or safety of Surfaxin in the approvable letters. Instead the agency has questioned the stability of the drug, as well as the manufacturing processes used to produce it - concerns that are much easier to address.
But the years-long approval battle has battered the stock and frustrated shareholders.
Discovery declined comment.
However, on a November conference call, Chief Executive Robert Capetola said he believes the company has addressed all of the issues raised in the FDA's most recent approvable letter.
Wedbush Morgan Securities analyst Kimberly Lee estimated the stock likely will surge to $5 if Surfaxin is approved, but could drop as low as 32 cents if the FDA issues another approvable letter. Lee said the potential market for Surfaxin is around $100 million.
Surfaxin is a surfactant, which are protein lipids essential for keeping airways in the lung open and allow breathing to occur normally. Premature infants are born before enough natural surfactant has developed in their lungs, which causes their air sacs to collapse.
"They cannot get enough oxygen in their blood to support their brain and other vital organs and they can't get carbon dioxide out," Capetola said at an April conference.
Analysts say the potential for Surfaxin lies in the fact it's synthetically produced unlike most other surfactants, which are derived from animal-based products. Surfaxin's synthetic make-up has the potential to make it more safe and effective than other surfactants, Lee said.
"Surfaxin is the first completely synthetic surfactant to perform as well as or better than animal-derived surfactants," Lee wrote in a recent note.
Dave Fondrie, senior vice president and portfolio manager of Heartland Funds, a long-time investor in Discovery, said Surfaxin's approval process has been disappointing. But Fondrie said his fund has stuck with the company due to a belief in Surfaxin's potential.
In particular, Fondrie likes the opportunity for Surfaxin to be used in aerosol form, which would be safer for patients than using tubes to inject the drug.
Fondrie said the FDA is likely to approve the drug this time, but if it doesn't, he added, he believes Discovery probably won't have enough capital to go another round and will be forced to sell the company.
Lee, who put 50-50 odds on Surfaxin getting approved, said the company can survive another approvable letter, particularly if the issues the FDA raises are minor. But she questioned the company's ability to survive if these issues surrounding Surfaxin last another year.
Meanwhile, Jefferies & Co. analyst Marko Kozul said in a March note that he believes Surfaxin will get approval on this attempt.
Discovery has other opportunities in its pipeline, including Surfaxin for the treatment of bronchopulmonary dysplasia - or chronic lung disease - which affects premature infants, and an aerosolized version of the company's Surfactant Replacement Therapies. These products, however, are in earlier stages than the version of Surfaxin currently up for FDA approval.
-By Jennifer Hoyt, Dow Jones Newswires; 201-938-2474; [e-mail]




ist ein bisschen, wie roulette an der börse...
bin über einschätzungen von euch dankbar -
soll keinesfalls eine kaufempfehlung darstellen

[starwarrior03]

hääää?? 4,81?? ich seh auch 4,70 mit über 7K Aktien da meint jemand wohl den kurs aus frankfurt..

[gnomli]

Antwort auf Beitrag Nr.: 36.982.430 von noa235 am 16.04.09 18:33:27

?? ich seh 4.70 ???

[noa235]

Schlusskurs Xetra € 4,81

[starwarrior03]

seht ihr was??