Replies to post #313504 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

They already have Orohan status and Rolling approval comes with RMAT. RMAT is the designation for RE division that approves this type of cell related treatment. It’s newer and better for this area and is not just FDA created, it was created by an act of Congress and the Office of the President. So it has a bigger, broader and more powerful mandate. It comes directly out of the 21st Century Cures Act that I mention frequently but seems to wiz over the conversations.

[sentiment_stocks]

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.