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trocprofit

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trocprofit

Re: flipper44 post# 415022

Thursday, 11/04/2021 3:52:52 PM

Thursday, November 04, 2021 3:52:52 PM

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We wouldn't be where we are today if endpoints were a concern. "acceptance," if you will, in whatever form the FDA conveys that, was done with the revised SAP and put to bed with data lock. We are in the complicated review process of a new (external controls) evaluation process and it is taking longer, that's all.
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