Biotech Values

[turtlepower]

ALTH - I am skeptical that the FDA will make a decision by the 24th and also that a decision will be positive. On one of the two previous occasions the fda granted accelerated approval the results in terms of response rate and duration were a lot better and on both occasions the companies had run two single arm trials.

"The FDA has based some approvals of oncology drugs on single-arm trials, Pazdur noted.

Eisai Inc.'s Targretin (bexarotene) was granted approval for CTCL in 1999 based on response rates of 54 percent and 45 percent in single-arm studies, with response durations of 107 days and 159 days, respectively. Merck & Co. Inc.'s Zolinza (vorinostat) also was given full approval in 2006 on the basis of response rate in two single-arm studies of patients with refractory CTCL, Pazdur added."

http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=51977

I listed to the CC yesterday and management stated that they had not submitted any material yet for another clinical trial. I consider that a huge red flag signalling at the very least a huge delay for a decision by the FDA. Given pazdur's prior history with Provenge I can only assume the worst.