Normy, It is unlikely that a phase three would ge
Post# of 153903
(Total Views: 502)
Posted On: 04/09/2021 7:31:26 AM
Normy,
It is unlikely that a phase three would get approved with ill defined endpoints and the phase two is designed to understand what a good bio marker might be for endpoints for a phase 3.
100 patients would get more data for endpoints and while it would take not take a lot longer, it would cost about twice as much which is always an issue for a small pre-revenue biotech.
To answer one of you other questions regarding EUA vs. full approval- EUA is a much faster review time vs. the standard full approval review times.
IMO
It is unlikely that a phase three would get approved with ill defined endpoints and the phase two is designed to understand what a good bio marker might be for endpoints for a phase 3.
100 patients would get more data for endpoints and while it would take not take a lot longer, it would cost about twice as much which is always an issue for a small pre-revenue biotech.
To answer one of you other questions regarding EUA vs. full approval- EUA is a much faster review time vs. the standard full approval review times.
IMO
(3)
(0)