News Focus
News Focus
icon url

Zadie420

10/12/24 2:03 PM

#725719 RE: flipper44 #725716

Thanks flipper for your reply. Very informative as usual.
icon url

dennisdave

10/12/24 2:24 PM

#725724 RE: flipper44 #725716

if that is the case, and you may very well be right, then that is a sign of weakness that would be incredibly disappointing. Having to bring in more evidence DCVAXL is efficient and safe than the current 10 year medical trial is an ooefff

Also if that is the case and the MHRA needs to review the results of the DC/CI analysis of the hose combination results then that will mean another 2-month delay. It doesn't make things less complicated
icon url

meirluc

10/12/24 3:48 PM

#725739 RE: flipper44 #725716

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".
Bullish
Bullish