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Re: Nemesis18 post# 698431

Friday, 06/14/2024 10:11:44 AM

Friday, June 14, 2024 10:11:44 AM

Post# of 702335
LL et all have stated clearly they do not have patient level data. She acknowledges that is an issue with using the P3 for approval while saying she hopes -L can be made available somehow (RTT, etc) while they run try to establish efficacy.

The FDA and others repeatedly state how patent level data is important for ECAs. They also talk about defining the protocol in advance of trial initiation. That biosec and others think the FDA does not know what they are talking about is odd.
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