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underpar71

09/29/25 6:17 PM

#790385 RE: Investor082 #790384

Disagree. They naturally asked questions related to crossover, change in endpoints, ECA and inspections. There were a lot of sites and a long time ago. I believe most questions to be rationale on making some of those decisions, which are able to be supported. And, on inspection/trial data which was as much as 15 years old. Either way I think it is just taking a long time. If there was something fundamental that would warrant denial, it would have happened by now, IMO.
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skitahoe

09/29/25 6:28 PM

#790387 RE: Investor082 #790384

We really don't know who they is.  One or more experienced contractors was brought in to help create the filing, in the end it comes from the company, but like most of what they do, others are helping. 
Gary