Dendreon Corp. (Nasdaq: DNDN)

Erinnere mich noch an Deinen totsicheren Tipp Sigmatel, erst noch ein Pick von dieser chotsverfl. Forbes-Schundliteratur. Daran kau ich jetz noch, kannst vielleicht mal Deinem Publikum erklären, was mit dem Sigmatel lauft und was sie damit machen söllten. Bei Kurs 14$ haben wir jetz nich mal mehr 5$, danke suggus.

Zitat von cybercrash

Kannst vielleicht mal Deinem Publikum erklären, was mit dem Sigmatel lauft und was sie damit machen söllten. Bei Kurs 14$ haben wir jetz nich mal mehr 5$, danke suggus.

Finde mich der Anklage schuldig.
Auch ich sitze noch auf einer Position SGTL und werde wohl noch ein Zeit lang dieses im meinem Depot im Blickfeld haben, leider.
Der Titel hat einen zusätzlichen Druck erhalten (Actions Semiconductor verklagt Sigmatel wegen Patentverletzung) die ein nachhaltige Erholung zu nichte macht.
Es bleibt mir halt auch nichts anders übrig abzuwarten bis sich SGTL übernehmen lässt oder einen guten "Schick" mit kooperationen macht.

Suggus

Vielleicht erwähnenswert, das Dendreon nach dieser Botschaft -60% einfährt, Quelle Nasdaq


Provenge - Proving Costly For Dendreon?



(RTTNews) - It is a 'Blue Wednesday' for Dendreon Corp. (DNDN), which has been issued an approvable letter for its investigational prostate cancer vaccine, Provenge by the FDA. The stain of this news has cratered the share price of Dendreon and is currently down over 61% to $6.85.

An approvable letter for a drug from the FDA means that the regulatory agency is prepared to grant approval only if the company meets certain conditions. Dendreon said that it is seeking a clarification from the FDA as to the nature of the data that is being requested.

Dendreon's Biologics License Application for Provenge was taken up for review by FDA's Cellular, Tissue and Gene Therapies Advisory Committee on March 29, 2007. The company completed the submission of its Biologics License Application for Provenge in November 2006, and the FDA accepted the filing and assigned Priority Review status for the application in January 2007. Priority review status is given to drugs that address an unmet medical need, and usually takes six months, compared with the regular 10-month review time.

The American Cancer Society estimates that 27,350 men died from the disease in the U.S. in 2006 and 234,000 new cases were diagnosed.

Though a clinical trial conducted with Provenge in 2000, which enrolled 127 men, demonstrated that the drug extended the median survival of the trial subjects by 4.5 months, another trial conducted with Provenge in 98 patients lacked statistically significant data on improving survival. (The time at which half of the patients enrolled in the study are still alive is the median survival time).

With results of the clinical trial of Provenge being equivocal, its approval remains a crap shoot and analysts had varying views on the possible decision of the FDA.

Brean Murray Carret analyst Jonathan Aschoff, who believes that Dendreon does not have strong data to gain Provenge approval, expected an approvable letter to be issued for the drug. Paul Latta, an analyst with McAdams Wright Ragen, expected the drug to be given at least a conditional nod. Joel Sendek, an analyst with Lazard Capital Markets was of the view that the FDA might wait for more study results and approve the drug in 2009. Under such a situation, he expects Provenge to garner sales of only $231 million in 2011.

But defying all odds, the experimental vaccine won the backing of the FDA panel on March 30, which voted 13-4 in favor of Provenge. It was widely believed that the FDA will also endorse the vaccine as the regulatory agency typically follows its panels' advice though it is not required to do so always. Following the FDA panel recommendation, Dendreon shares had more than doubled in value to close the trade at $12.93. The FDA was expected to take a final decision on the drug on May 15.

According to Needham & Co., an investment banking and asset management firm Provenge, if approved in 2007 could reach $1 billion a year in peak sales by 2011. It appears that at least for now, Dendreon, a one-trick pony with everything riding on Provenge, is still not near the finish line.

@ADmini - bitte in Bereich High Risk verschieben