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Post# of 257419
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exwannabe

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exwannabe

Re: bladerunner1717 post# 142486

Wednesday, 05/23/2012 9:27:34 PM

Wednesday, May 23, 2012 9:27:34 PM

Post# of 257419

Dr. Ron Garren says that CLDX will try to do a small, single-arm study with PFS as the primary endpoint under "accelerated approval."



Wow.

Does not the FDA clearly not consider time based endpoints in single arm studies for registrational purposes (even accelerated)?

Who is smoking what?
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