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Re: MI Dendream post# 315947

Friday, 10/09/2020 1:34:01 PM

Friday, October 09, 2020 1:34:01 PM

Post# of 822872
That’s a good insight and explanation into how the communication between a trial sponsor and FDA comes about - makes perfectly good sense.

Generally you would expect something along those lines, just because actual approval is such a formal process that nobody can make a firm representation that in the end everything will be accepted and approved. Frankly, that might be true involving any type of government approval.

But the odds of approval are just so much greater when there is staff buy in, since those are the people making the internal FDA recommendations.
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