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Re: Bill B post# 662574

Tuesday, 01/09/2024 10:33:48 AM

Tuesday, January 09, 2024 10:33:48 AM

Post# of 821082
I'm assuming they're not proceeding under the 150 day route until they tell us. They requested to the MHRA to proceed under rapid review but unless they notify us they are, I can't assume that as per their Dec 21st PR which states

The application also requests to be considered under the MHRA's rapid 150-day review pathway, which the agency has established for new medicines for serious unmet medical needs.

Unless notified otherside via PR or 10q etc, I have to assume it's being reviewed under standard review so maybe approval at this time next year. I know DCVax-L is a great drug w great results and is for a serious unmet medical need and a strong candidate for the 150 day rapid review so I'm expecting it will get accelerated review. Here's hoping.
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