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Re: Doc logic post# 313484

Friday, 10/02/2020 10:45:47 AM

Friday, October 02, 2020 10:45:47 AM

Post# of 823422
I think that is a correct interpretation. Though I don’t think they are at that point yet.

I suspect they are seeking RMAT, and RMAT came out only a few years ago, long after their trial started. So it would be unusual to seek it now but not necessarily unreasonable, given the nature of the trial. It would give them many potential benefits including a speedy route to accelerated or conditional approval, I believe.

Certain applications, if they are rejected for purely procedural reasons would not be wise to publicize unless they are granted. Hence, if the agency is just taking its sweet time, it would make sense why no PR.
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