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Posted On: 02/17/2021 4:20:40 PM
Post# of 148899
I would say we would get and EUA first because the FDA isn't going to fully approve a drug on such a small trial, especially because LL could then be use off label for multiple indications. I think they are going to want to see even more safety data which may be accumulating right now in the OLE.
Saying all that, I think the FDA, Janet W. the Biden admin would love to get a WIN or just the good PR. and get this out there ASAP if the data is good.
Saying all that, I think the FDA, Janet W. the Biden admin would love to get a WIN or just the good PR. and get this out there ASAP if the data is good.
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