“However, prior to getting the "don't bother fil
Post# of 153822
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Posted On: 11/12/2020 9:25:03 PM
“However, prior to getting the "don't bother filing recommendation" from the FDA, NP expressed the opinion that moderate population met unmet medical need, so there's no reason he wouldn't feel the same for LH population, and consequently seek EUA if LH ph2 met PE with stat sig.”
NP’s opinion has failed many times in the past. He once thought data from 2 cancer patients was sufficient for a BTD packet, which was denied by the FDA. NP referred to that denial as a “strike against the company” on a recent CC and stated that strike was why he didn’t file for EUA with the M2M data and instead asked them to give their opinion.
So, his opinion that an EUA for the longhauler trial has no relevance to actually what constitutes a legitimate FDA EUA indication. None of the EUAs so far have been given for a 100 person trial and I our longhauler phase 2 trial will change that.
NP’s opinion has failed many times in the past. He once thought data from 2 cancer patients was sufficient for a BTD packet, which was denied by the FDA. NP referred to that denial as a “strike against the company” on a recent CC and stated that strike was why he didn’t file for EUA with the M2M data and instead asked them to give their opinion.
So, his opinion that an EUA for the longhauler trial has no relevance to actually what constitutes a legitimate FDA EUA indication. None of the EUAs so far have been given for a 100 person trial and I our longhauler phase 2 trial will change that.
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