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DewDiligence

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Re: willyw post# 2276

Tuesday, 08/02/2022 4:05:44 PM

Tuesday, August 02, 2022 4:05:44 PM

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If Luly can provide some color on what the approval process is it would be great.

The CC next week is too soon for Luly to provide any detail. ENTA needs to meet with the FDA to get a buy-in on the trial design and endpoints. I expect ENTA to seek a pivotal phase-2/3 design, but it’s unclear if the FDA will concur with such a plan.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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  • 1M
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