Well craig, as far as I am concerned, the ph-2 ofo
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Posted On: 01/03/2021 6:43:54 PM
Re: craigakess #70955
Well craig, as far as I am concerned, the ph-2 ofour M2M was done for it's safety and it proved that Leronlimab was very safe indeed. NP said he was. or was going, or did ask for EUA but fda said, we don't think so, now proceed to ph-3. I give Dr. NP credit for at least throwing in that question to the fda. So, IMO, ph-2's are really not for asking for approvals, all though, it has been done b4 so it sets us up for ph-3 which is hopefully going to get Leronlimab an EUA or full out approval I hope but nothing is guaranteed in this life, just hope.
As for the EIND's they were great along with the results of the M2M but again Craig, ph-2's are mostly to show the drug is safe and a company can proceed to phase 3 so that is why, IMO, the fda said no thank you and what they might have said to Cytodyn was, show us the proof of your concept in the final results of your phase-3 so here we are waiting just for that
HCIT
As for the EIND's they were great along with the results of the M2M but again Craig, ph-2's are mostly to show the drug is safe and a company can proceed to phase 3 so that is why, IMO, the fda said no thank you and what they might have said to Cytodyn was, show us the proof of your concept in the final results of your phase-3 so here we are waiting just for that
HCIT
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