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Re: biomaven0 post# 129966

Tuesday, 11/01/2011 2:03:32 PM

Tuesday, November 01, 2011 2:03:32 PM

Post# of 257685
Exactly. There is no need to seek SPA for 307 alone. EXEL probably should have sought SPA for 306 along with 307. That might have changed the equation for FDA to consider 306 portion SPA. FDA review 306 SPA could only take consideration of what was submitted, not what else you had in development plan.

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