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HDGabor

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HDGabor

Re: Biobillionair post# 28349

Friday, 05/30/2014 7:49:00 AM

Friday, May 30, 2014 7:49:00 AM

Post# of 406256
Great summary. We could say - rewording the FDA's 'Guidance for Industry Special Protocol Assessment' - the SPA rescission is not bindning since 'Failure of a FDA to follow a protocol' and 'the relevant data, assumptions, or information provided by the FDA in a resicission for special protocol assessment are found to be false statements or misstatements or are found to omit relevant facts'
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