Replies to post #243332 on Biotech Values

[vinmantoo]

I expect ENTA to seek an FDA buy-in to run a pivotal phase-2/3 trial, instead of a straight phase-2. The FDA may not concur with such a plan, but they would (IMO) be derelict in not doing so, given the potential utility of EDP-235 in mitigating the pandemic.

That would make me happy and obviously hasten the potential approval time.

If ENTA does get an FDA buy-in to run a pivotal phase-2/3, then a partnership deal up-front becomes considerably more likely, IMO.

I figured we would get at least a $5-$10 price increase if the safety and pharmacokinetic data was good so my guestimate is no so bad. The fully realized rise may take a few days given how lightly traded ENTA is. Given it is friday, today's close could be quite interesting. In any event. I nibbled and bought a little more today after the data release. Obviously a partnership deal would drive ENTA stock price much higher. Nice way to start the weekend.

[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.