The dosage discussions in the pre-print were waaaaaaayyy over my head as well. I was responding to your assertion that "The FDA didn't see any issues with this P2 trial".
We know what those dosages were but we don't know how the FDA viewed them. It would be good to know that before we took the next step that you took:
"We had used prior studies to move past P1, so any SAEs would have been covered."
The FDA accepted the dosages used in Phase 2, but we don't know which of those dosages were acceptable to them in Phase 3 or, if alternative dosages were recommended, what they were.
That's different than the current trial, where the FDA has either accepted whatever dosing the Company has proposed or some other dosing regimen has been agreed upon by both parties. It's a done deal.
The thing that the proposed P3 B-ABSSSI trial and the IND enabled Covid B trial have in common is the lack of public info regarding dosing.
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