Biotech Values

[DewDiligence]

Re: EDP-235 phase-2 design

Looks like they are picking patients who are in pretty good shape.

They are. The EDP-235 phase-2 trial is too small to have sufficient statistical power for such metrics as the rate of hospitalization; rather, the purpose of the phase-2 is to gather more evidence on safety and viral loads and to select a dose (or doses) for phase-3. In phase-3, the tested population will almost certainly include high-risk patients.

Since the phase-2 trial does not intend to show a statsig reduction in the rate of hospitalization, enrolling average-risk patients will not cause the trial to fail statistically. What it will do is speed up recruitment and thereby shorten the time to the onset of phase-3.