Thursday, April 03, 2025 5:33:51 PM
I see it in a different light. Back engineering what transpired, one, or at least I, come to a different conclusion. Advent had to be built up; Cognate was several years ahead of them. They had solidly established manufacturing here in the US w Cognate, and the US is the most desirable market to launch so why pivot to Advent/MHRA when you had the marbles lined up for the US? There was no LP greed involved as some assert, it was strictly because the FDA may have thrown up some roadblocks, and LP sensing receptiveness from the MHRA via Dr Ashkan, saw it as the easier road to navigate. And yes, I see the EMA application next in line, hopefully before the end of the year. Sawston serving the EU makes lots of sense.
Regarding, the FDA mandated control arm, I don’t think anybody (FDA/clinicians) foresaw the PSPD created by the DCVax-L arm, throwing a monkey wrench in the data w the FDA then having an issue w the non-patient level ECA. After MHRA approval, and as RWD/RWE accumulates w the specials program, I think that will ameliorate a pathway to FDA approval. That’s my take and whatever you said in your previous post or say in a future post will not change that.
Regarding, the FDA mandated control arm, I don’t think anybody (FDA/clinicians) foresaw the PSPD created by the DCVax-L arm, throwing a monkey wrench in the data w the FDA then having an issue w the non-patient level ECA. After MHRA approval, and as RWD/RWE accumulates w the specials program, I think that will ameliorate a pathway to FDA approval. That’s my take and whatever you said in your previous post or say in a future post will not change that.
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