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flipper44

02/19/23 7:32 PM

#569159 RE: hoffmann6383 #569156

Rolling components are “preassessed”

I’m not sure that constitutes “in the process of being approved.”

Waiting for MHRA to respond.

biosectinvestor

02/19/23 9:43 PM

#569179 RE: hoffmann6383 #569156

The Innovative Licensing program in thebUK, or ILAP both allows for a rolling approval AND the company and MHRA develop a plan before the application that entails things like manufacturing and broad issues to guide the drug toward approval. They develop a Target Development Profile with the regulators, or a TDP. It has long been my view that NWBO was the ideal drug for this relatively new program and is likely a part of that program.



If you read my thread you will see that early interaction with NICE is a part of this pathway.

See the below graphic from my above Twitter thread. Note the language at the top of this graphic, and the pathway at the very bottom of the graphic. Looks a lot like what we are seeing with NICE and MHRA working together simultaneously rather than sequentially.

Bullish
Bullish