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Re: Jonjones325 post# 284494

Saturday, 11/21/2020 11:52:22 AM

Saturday, November 21, 2020 11:52:22 AM

Post# of 519066
We will have to see if we get both PD and PDD trial or one combined.

450 might be a good guess, but it will depend on the full current analysis, agreed endpoints and expected effect size.

With a P3 pivotal trial everything is at stake demanding a well conducted trial that won’t raise criticism when it comes to filing the NDA and hence more planning and monitoring required likely across continents.

All great and expected stuff.
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