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FACT-MASTER

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FACT-MASTER

Re: None

Tuesday, 02/27/2024 9:14:42 PM

Tuesday, February 27, 2024 9:14:42 PM

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I don't think there is a set timeline for FDA approval, once RMAT designation is received.

Combining RMAT with Accelerated Approval and Priority Review would greatly reduce the timeline for approval and to reach the market.

Article of Interest regarding RMAT:

https://www.pharmacytimes.com/view/regenerative-medicine-advanced-therapy-the-latest-special-fda-designation
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