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BTH

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BTH

Re: DewDiligence post# 102718

Friday, 08/27/2010 11:25:47 AM

Friday, August 27, 2010 11:25:47 AM

Post# of 257657
I don't agree. I think the FDA really doesn't have any rhyme or reason as to how, why, or when they approve something. It's a crapshoot any time you're dealing with the FDA. They have surprisingly approved some drugs that NO ONE ever expected would be approved (for what reason, who knows), and others, like this, they delay (like Provenge which showed clear evidence of efficacy).


A good overview:

http://www.pharmastrategyblog.com/2010/08/fda-rejects-the-roche-immunogen-t-dm1-accelerated-approval-filing.html

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