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Re: flipper44 post# 725716

Saturday, 10/12/2024 3:48:13 PM

Saturday, October 12, 2024 3:48:13 PM

Post# of 810634
If the MHRA has decided to delay the MAA approval only after it has taken a peak at
the preliminary results of the DCVax-L/keytruda, rGBM combo trial, we may have
to wait for that approval at least until sometime in December because the pertinent
data will not be available before December 1. IMO, this delay's only positive feature
would be the shorter interval between MAA approval and the validation of EDEN.

"When the unblinding was accelerated from August 2025 to December 2024, I didn’t think the MHRA wanted a peak prior to decision, but when the unblinding was moved to September 11, 2024, I’ve become more convinced the MHRA will
take a look at those trials before their decision".
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