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flipper44

04/02/24 10:32 AM

#682762 RE: BuccaneerIllusionist21 #682757

I think the standard is lower there with compassionate, but I don’t disagree. Perhaps what is more telling is that LP finally pulled the trigger on submitting an MAA for regulatory inspection. LP would not have done that without minimizing risks from every conceivable angle and some level of educated assurances from former regulators who are consultants. IMO, even continuing trial maturation, which no one really thinks about anymore, likely buttresses DCVax-l’s prospects.
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flipper44

04/02/24 11:27 AM

#682776 RE: BuccaneerIllusionist21 #682757

BTW, the MHRA approved DCVax-l for compassionate use about a decade ago. You are thinking about Sawston’s license to manufacture for compassionate, which happened about two years ago. Prior to that, it was made exclusively in London for compassionate.