Replies to post #240266 on Biotech Values

[radford]

I think you are way off here Dew. By everything I can see, the Enanta product is far superior to the Pfizer product. Enanta may have to partner in order to get the regulatory access they need to streamline approval but they should be able to do that on very favorable terms. If Pfizer results (which are from an interim analysis) hold up, you can forget Merck or Roche, the contest is between Enanta and Pfizer. Yes, Enanta needs to get into the clinic, but small molecule trials on a therapeutic are much easier to conduct than RCTs on vaccines. The Phase 1 Enanta is planning is on 75 healthy volunteers, how hard should that be to enroll?

[LongRun8]

I think you're probably right, especially since ENTA will likely not be able to get EUA by the time their data (assuming it's good) has been revealed. That just adds to the timeline having to wait the full time for NDA. I guess we'll just have to see if Covid is endemic by then, how the world stands with vaccinations, and which variants might emerge and wreak havoc.

[vinmantoo]

All told, investors should expect ENTA to need at least two years from the FDA’s IND acceptance to the NDA submission. (The EUA path may no longer be available by then.)

Still, even at a slower development pace, EDP-235 could be an immensely valuable asset.

Dew, that seems like a reasonable estimate. I will point out that ENTA's EDP-235 could provide great value to ENTA well before approval. If the early trials show excellent efficacy and safety then ENTA then you can be sure they will be able to find a partner to complete development and strike a good deal at better terms than they got for their Hep-C drugs. Obviously final FDA approval would be required for maximum benefits for ENTA and ENTA shareholders.