NorthWest Biotherapeutics Inc (NWBO)

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RMAT designations are intended to “roll the BLA” along faster as well. It is a designation that should fit very well to DCVax-L, should they pursue it.

By definition, an RMAT is an award from the U.S. FDA that allows for faster, more streamlined approvals of regenerative medicine products within the United States, such as cell and gene therapies, tissue engineering products, and combination products. RMAT designations make innovative products eligible for quicker development and review of a marketing application.

An RMAT designation is similar to the breakthrough therapy designation that is available to drugs.

Benefits of an RMAT include increased opportunities to meet with FDA officials, as well as early meetings to discuss potential surrogate or intermediate endpoints.
https://www.google.com/amp/s/bioinformant.com/rmat/amp/

An RMAT wouldn’t guarantee approval, but it certainly would significantly speed up the time to wait for an FDA approval. And that would be a good thing, especially for GBM patients who’ve proven time and time again that time has NOT been on their side.