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biolover

11/07/21 3:25 PM

#240265 RE: LongRun8 #240264

100 percent ENTA is wayyy behind . And Pfizer data came out much better than I thought . They are master marketer , their drug will become synonymous with Lipitor by the time ENTA drug comes to the market . With Covid slowing down tremendously will be very hard for them to run trials now that’s another hurdle to think of IMO. Would like to know other folks opinion on this

DewDiligence

11/07/21 3:35 PM

#240266 RE: LongRun8 #240264

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.