Dendreon Corp fka DNDNQ

[gofishmarko]

WSJ.com commentary : "Cancer Regression"

( Edit : Oops ! I see nmstav beat me to it. )


CEO of Pharmacyclics on FDA policy of " Decelerated Approval "


http://www.investorvillage.com/smbd.asp?mb=971&mn=147659&pt=msg&mid=2683253

or

http://online.wsj.com/article/SB118593325021784255.html?mod=opinion_main_commentaries&apl=y


The list of biotech execs who have publicly criticized the FDA recently grows longer. They do so knowing that they risk blowback when their companies must go before the FDA seeking regulatory approvals , which , IMO , adds credence to their arguments.


This line near the end of the article sums it up pretty well , I think :

" Clearly we need to get back to a more context-sensitive regulatory approach for reviewing drugs targeting deadly diseases. That is not to say that rigorous scientific principles should be abandoned. But in medicine, ethical and practical considerations have to play a role too. "