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Re: LongRun8 post# 240264

Sunday, 11/07/2021 3:35:23 PM

Sunday, November 07, 2021 3:35:23 PM

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You’re right—ENTA won’t be able to match PFE’s speed from IND to end of phase-3. For starters, it will take ENTA longer to enroll the open-label phase-1/2 trials in geographies where PFE’s regimen is available. (In phase-2/3, ENTA may to have to go head-to-head against PFE rather than against placebo.)

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.

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