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Re: ahp123 post# 475141

Wednesday, 05/18/2022 6:30:12 AM

Wednesday, May 18, 2022 6:30:12 AM

Post# of 700350
One Golden Rule in this industry… Never Speak Publicly for FDA.

Agree, any expectation for them to do so is misguided

Changing the Clintrials posting at this time tells you everything you need to know. The SAP needed to be submitted and accepted prior to data lock. LL confirmed that FDA ‘accepted’ this in their typical manner by not rejecting it within 30 days. This does not allow them to change the posting and speak for FDA without definitive permission to do so.

Ask yourself what has changed? There is another 30 day timeline that matters right here, right now despite JMJJs criticism of my views.
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