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DewDiligence

05/25/12 4:00 PM

#142628 RE: iandy #142627

ELN—I wouldn’t read anything in particular into the quoted statement in your post, which purportedly came from some unnamed individual at the FDA. What’s more consequential, IMO, is the BoD’s apparent willingness to sell the company (#msg-75983229).
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iandy

05/25/12 4:15 PM

#142631 RE: iandy #142627

I suspected you could throw the normal DFA expectations out for this drug.



Sorry for the typo.
It should have read FDA not DFA.
I doubt the Dairy Farmers of America have any say in the matter.
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masterlongevity

05/25/12 5:52 PM

#142656 RE: iandy #142627

they will still need a significant effect on one clinical endpoint and a biomarker. The biomarker is given, but the clinical benefit is the open question. The bar has not been officially lowered but Katz's comments last week did make it clear that he might not need positivity on 2 clinical endpoint, as is usually required in AD.