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Re: None

Thursday, 04/06/2017 6:55:17 PM

Thursday, April 06, 2017 6:55:17 PM

Post# of 106839
My RMAT Analysis

Here is what I am guessing happened. They probably submitted the RMAT on January 30th and it was reviewed and sent back to them on March 30th. That would meet their 60 day requirement and we all know the FDA waits until the last minute to respond.

The FDA then requested additional information. So that means that they likely had to resubmit it and got moved back.

We should expect that it could take until 5/30 to hear back unless someone can find a policy on responding to re submissions.