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DewDiligence

01/19/22 1:17 PM

#2149 RE: vinmantoo #2148

What takes a lot of time is generating enough API for high-volume output. Producing small amounts of the drug for early-stage clinical trials is not a problem.
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willyw

01/19/22 1:30 PM

#2150 RE: vinmantoo #2148

I cannot comment on that with any knowledge or authority.
Years back when I was in a Gilead trial I was curious where the drug batches came from for trials. I'm in Iowa, and as it happened it seemed that one location may have been my hometown.

I think there may be a difference between the early trials and small batches and the large scale final formulations. Recall that in NASH Enanta shifted I think from a liquid to pill form which changed the bio-availability.

I think both Enanta and Pardes maintained they had adequate funding (and I think adequate supply) until such a time as large amounts of drug (and I'd suppose some registered/validated process of mass production) was required. I'm absolutely out of my depth here. : )

I also wonder if the EUA amount of drug required, let's say for a phase 2 is less than a standard amount for a full blown standard phase 2. It seemed to me that in vaccines one of the criticisms was that the FDA was proceeding with scant data -based upon trial participant cohort size.

Finally, the trial I was in I was in a 24 week once a day 200mg dose. (if I correctly recall)
In the case of Enanta it could be once a day between 100 to 500mg for 5 days. That's a large difference in quantity required.