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FeMike

05/21/25 5:18 PM

#768807 RE: dennisdave #768800

In summary, while the precise influence of the HTA "Procurement" license addition on the MAA approval timeline is uncertain, it appears to be a significant milestone in ensuring compliance with regulatory requirements for ATMPs like DCVax-L



Welp, here comes Debby Downer.

I'm not saying you or AI's analysis is wrong. Could be right.

But I feel like there is at least an equally strong likelihood (if not more so) that this is related to Direct restart and not -L?