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Posted On: 03/18/2021 2:14:12 AM
Post# of 148878
I agree but it appears they applied for EUA. My question is if we get EUA is CD16 still a phase 3 trial and then after CD16 if we hit the endpoints we can get approval or do we move to a phase 4. Probably a dumb question.
I just was under the impression we weren’t going to file for EUA or it wasn’t clear. So did the FDA request that we do or did we do this on our own?
Interesting PR. We just had a CC so I’m assuming there must be something substantial to call to have another meeting so soon. Regardless I’m looking for some actual clarification as to the BLA.
If it was just an update NP would have done a proactive video IMO.
I just was under the impression we weren’t going to file for EUA or it wasn’t clear. So did the FDA request that we do or did we do this on our own?
Interesting PR. We just had a CC so I’m assuming there must be something substantial to call to have another meeting so soon. Regardless I’m looking for some actual clarification as to the BLA.
If it was just an update NP would have done a proactive video IMO.
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