“From the wording it seems to me that for Cytody
Post# of 153864
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Posted On: 12/25/2020 10:45:46 PM
“From the wording it seems to me that for Cytodyne to receive FDA approval to charge patients under the EIND protocol it would require all of the same "stuff" necessary to win EUA approval from the FDA.”
The FDA approving EINDs and possibly approving an open label extension is similar in very few ways that of the FDA granting of an EUA or full approval. Yes, for EINDs and label expansion, the FDA looks at safety, but that’s about the extent of the similarities. Recall that the FDA granted CYDY EINDs to treat COVID patients when there was no efficacy data, only safety data. This is the same for mTNBC or cancer patients, although those had pre-clinical animal data supporting the potential use. The continuation of EINDs for COVID S/C should be of no suprise and they will continue until the S/C trial succeeds or fails. The same goes for label expansion, which again, is not indicative of an approval but a reflection of established FDA process that any biotech can apply for. The FDA granted CYDY a label expansion for the 350mg HIV combo trial which finished in 2018 and according to clinicaltrials.gov, is still ongoing.
The FDA approving EINDs and possibly approving an open label extension is similar in very few ways that of the FDA granting of an EUA or full approval. Yes, for EINDs and label expansion, the FDA looks at safety, but that’s about the extent of the similarities. Recall that the FDA granted CYDY EINDs to treat COVID patients when there was no efficacy data, only safety data. This is the same for mTNBC or cancer patients, although those had pre-clinical animal data supporting the potential use. The continuation of EINDs for COVID S/C should be of no suprise and they will continue until the S/C trial succeeds or fails. The same goes for label expansion, which again, is not indicative of an approval but a reflection of established FDA process that any biotech can apply for. The FDA granted CYDY a label expansion for the 350mg HIV combo trial which finished in 2018 and according to clinicaltrials.gov, is still ongoing.
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