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martyDg

06/29/25 2:27 AM

#773371 RE: meirluc #773363

Question now is....Is it possible that the MHRA has to wait until officially publishing the final guidelines on using ECA-based RWD before making a regulatory decision on DCVAX-L?
Given that the feedback deadline is on July 14, and it may take 2 to 4 months to finalize and publish the guidelines, the approval for DCVAX-L could be pushed back to 2026.
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Zadie420

06/29/25 9:00 AM

#773388 RE: meirluc #773363

You hit the nail on the head. I think MAA approval is in the bag. Hopefully they will release it very soon.,