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Re: randychub post# 2280

Tuesday, 08/02/2022 9:01:15 PM

Tuesday, August 02, 2022 9:01:15 PM

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How many drugs get thru phase 1 with that type of data and never get approved or take a few years at minimum to get approved.



How long it take depends on the disease being treated. Cancer trials take many year or run. A drug to inhibit a rapidly dividing virus can take two weeks per patient. The EDP-235 trial will be 5-7 days of treatment. You give it 2-3 weeks more to assess the outcome for each patient. There are no sure things but I feel pretty good about the chances for EDP-235 success.

Pfizer's Paxlovid phase 2/3 trial for high risk patients started in July 2021. The interim analysis in November 2021 showed excellent efficacy so they stopped enrolling. The final data was ready on December 14 2021 and submitted.

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-additional-phase-23-study-results

The FDA approved Paxlovid on Dec 22, 2021.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19
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