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TempePhil

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TempePhil

Re: powerwalker post# 297172

Saturday, 02/06/2021 6:16:25 PM

Saturday, February 06, 2021 6:16:25 PM

Post# of 462259
Power, looking at the wiki link you provided, seems to me, to imply that these 66% more sites (and patients), being added now, near the end of the 450 enrollment, would be to preclude having to run a second phase 3 trial, needed to get additional regulatory agencies on board for approval (EU/FDA/Canada). (Sorry for the run on sentence, fourth grade teacher please ignore.)

Since phase 4 is for post marketing (after approved for sales), surveillance monitoring of the drugs affects.

I suppose not having to run an extra p3 trial, is worth the extra additional months. Its just that I have been waiting a long time already lol.
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