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Msg  18354 of 18375  at  9/18/2023 5:02:59 PM  by


4157 P3 trial

I see, said the blind man.  Despite the price pounding today, I think I came up with a logical reason why the only P3 trial sites to date (6) are in Australia (all recruiting) and none are any where else in the world. I've been pondering why none in the US, especially near Boston where Moderna is wired to the medical research community?
I think it is to accelerate the additional 100 participants added to the P2 trial shortly after interim results were reported, which I believe will be the basis for an accelerated approval BLA to be filed, I hope in 4Q. I just looked at this trial profile. Of 22 study sites, 17 are in the US and 5 of those are currently recruiting. The other 5 study sites are in Australia and none of them are currently recruiting.
It's also obvious from the recent R&D presentation, including the slides, that Moderna is trying to get FDA to accept an accelerated approval application for approval based on P2 results as augmented by more time on the original 157 with added statistical significance coming from the new 100. 
So, the faster they can get an additional 100 added to the P2, the faster they can be eligible for accelerated approval. Recruiting for P3 in the US now will dilute the number applying to join the P2.
I don't know that this is the reason (or one of them) for all-Australia study sites to date, but it makes sense to me. Cram the US population to fill the P2 before opening US sites for P3. 

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Msg # Subject Author Recs Date Posted
18367 Re: 4157 P3 trial profile amendment dar200 0 10/19/2023 10:15:27 AM

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