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Re: ClosetInvestor post# 215198

Monday, 10/31/2022 9:19:09 AM

Monday, October 31, 2022 9:19:09 AM

Post# of 232696
Yeah, NP played a big role in the failure as well with the BLA, getting on the bad side of the FDA. But the FDA greatly hurt. In my opinion, if the FDA wanted it approved, it would be approved. Specifically their restrictions were so strict it too forever to get the trail filled. Then the added additional safety requirements. The the dose change talk different than the trial. Then they added a RO requirement. None of that was needed if you are hit 80% when the previous approval was below 50% with this population in my opinion, especially given the safety history. Again, JMO.
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