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Re: biomaven0 post# 114706

Monday, 02/14/2011 4:19:40 PM

Monday, February 14, 2011 4:19:40 PM

Post# of 257261

I think it is a mistake to extrapolate the FDA's resistance to accelerated approval with marginal (or even respectable) efficacy to their likely reaction to any display of spectacular efficacy.



Exactly.

Or what about a similar trial in CRPC mets with a pain endpoint.

IF, as the investigators have said the pain suddenly stops "like turning off a light switch" - it should be apparent very quickly. One of the patients said his pain stopped after 3 days on XL184.

ij

There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)

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