Biotech Values

[DewDiligence]

Re: EDP-235 clinical-trial plans

On yesterday’s CC, Jay Luly may have slipped up by inadvertently revealing that ENTA is seeking to conduct a phase-2/3 trial for EDP-235 (rather than separate phase-2 and phase-3 trials). From the CC transcript:

https://www.fool.com/earnings/call-transcripts/2022/08/09/enanta-pharmaceuticals-enta-q3-2022-earnings-call/

“…generally speaking, the concept on the phase 2 piece would be fairly small and then we would head in to the larger [i.e. phase 3] portion, which would be registrational, obviously.”

I don’t think any of the analysts on the call caught this.

ENTA needs a buy-in from the FDA to run a phase-2/3 trial, of course.

Luly also said that the EUA regulatory pathway for EDP-235 is still open.