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Re: namtae post# 253346

Tuesday, 05/02/2017 3:14:18 PM

Tuesday, May 02, 2017 3:14:18 PM

Post# of 402390
Yeah.... the Elite execs just walk in the meeting door and ask one question. The FDA says "yes" and that's the end of discussion.

Elite execs walk back to their vehicle and leave.
Seriously nammy?

Reality check.... there is a serious discussion as to solutions to
a CRL between the FDA and the pharma. Yes. the FDA does give guidance on what the pharmaceutical may need to accomplish during testing. What options are available...
Elite had 3 solutions.... of those 3 the FDA liked all.

It is not cut and dry as you propose it to be.



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