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Posted On: 04/09/2021 7:31:26 AM
Post# of 154635
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
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