Unless I am totally wrong and you can not get a Ap
Post# of 147586
(Total Views: 514)
Posted On: 02/19/2022 1:15:21 PM
Re: Goosebumps #118680
Quote:
Unless I am totally wrong and you can not get a Approved jump for phase 2 to BLA approval with Fast Tracked Status and do a confirmation trial as a phase 4 trial.
Accelerated approval is available but even if our median overall survival was 18 months + that probably would not be compelling enough for the FDA due to small trial size. There would be that possibility at interim phase 3 with a sufficient number of patients.
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