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Re: pgsd post# 663222

Thursday, 01/11/2024 11:31:26 PM

Thursday, January 11, 2024 11:31:26 PM

Post# of 700340
That’s a good point pgsd. I don’t think Dr. Ashkan is out of touch at all, and I’m quite sure that being the point man in the UK for DCVax, he knows better than most what’s possible with the MHRA regarding a potential rapid approval. I do think that, when you are speaking like he was, and responding to questions, his statements shouldn’t be taken quite so literally as some seem to, but rather “a few months” could easily mean six, which is actually still quite fast for a regulatory approval.

I’m not disputing that there are politicians, clinicians, patients and their advocates that desire a very rapid approval for DCVax, some with great influence and knowledge about the MHRA and the process. I personally don’t think that the UK government would view DCVax approval with the same urgency as the Covid treatments, but I certainly don’t know. I’m just saying that after COVID, even innovative treatments that are desperately needed by patients in the UK, have not received the rapid approvals that were promised by these very same politicians and KOLs.

No one is closer to, or more knowledgeable about the capabilities and interworking of the MHRA than it’s own Deputy Director of Innovative Medicines, so when that person says that the goal is to get to 150-day approvals, but they’d be happy with 210 days, that means more to me than some fluff by a politician, or even an estimate by a very knowledgeable clinician.

I knew my approval estimate would not be popular on this board, but I’m not here to get “likes,” just sharing my opinion, and reasoning. I agree with you though that "anything is possible."
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