Monday, October 31, 2022 10:37:59 AM
I briefed through the FDA response to the BLA. I thought it mentioned the RO requirement. The trial requirements I read on clinical trials.gov. The trial protocol was standard compared to other combos I read. The safety requirements was put in a PR, so I strongly suspect it was correct. And remember PRO 140 was sidelined because they thought the FDA was requiring too much, 10+ years to approval, even before NP. And NP, I have said publicly on several occasions and privately to you I believe through PM, his greed in the 2020 salary increase was the reason I stepped away before. So I am not here to defend him. There is a lot of blame to go around, NP also. We both know I kept a close watch on his statements and the results back then to make sure they were in alignment.
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