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mouton29

03/02/17 3:35 PM

#16924 RE: DewDiligence #16923

The word "may" seems to be their standard language, it appeared in the TEVA letter I linked to and the first 6 others I clicked on. The word still may mean what you think it means, but one question would be, has the FDA ever in fact, approved a product produced in a facility receiving a warning letter.
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alternatepatel

03/07/17 1:31 PM

#16959 RE: DewDiligence #16923

I doubt FDA really cares, or that "may" was put there intentionally. If FDA really wanted to approve this thing, they could have acted a lot more differently (probably proactively). The worst thing is, we don't have a PDUFA date or TAD, so FDA may choose not to respond to the sponsor as long as they wish.