Tuesday, August 01, 2023 6:01:49 PM
I believe that your assumption that the UK and other regulators won't approve is wrong for two reasons. The first is that I believe that DCVax-L will be the first applicant to show it increases 5 year survival dramatically. Granted, other products in trial may be achieving comparable numbers, but not dramatically better. The second, and really most important one is that the regulators are not deaf, dumb, and blind, they know that DCVax-L is opening the door to treatment by a number of existing therapeutics that previously failed in GBM that suddenly take survival at 5 years to 50% or greater, roughly ten times what's achieved by the current SOC. To ignore such information and demand years of additional trials on their part would be malpractice by the regulators IMHO. Likewise, post approval it would be malpractice for a Dr. to use DCVax-L and not use one or more of the existing therapeutics documented to dramatically increase the efficacy of DCVax-L.
Gary
Gary
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