Tuesday, November 12, 2024 7:14:56 AM
Some reflections.
Those fast upcoming multiple combination trials LP discussed at the ASM, might very well be initiated in the UK utilizing the newly created MHRA phase i, ii, and iii trial templates for standardized studies. Where, in those cases, tumor shrinkage/response will accelerate the process for various cancer indication trials. I also believe the EDEN automated system utilized in facilities and point of care will additionally standardize those trial (and commercial) processes. These appear to be major components of a master plan.
Until recently, standardization systems (e.g. trial templates, automated closed system manufacturing) has been the once quiet giant infrastructure being cooperatively developed by industry, regulators, institutions/hospitals and other collaborators. Quiet no longer. And yes, sorry not sorry to bears, it would seem DCVax’s platform is an integral initial subject used to run the gauntlet for this new UK structure. Lest we forget MHRA’s recent comment that in the future she, Dr. June Raine, (retiring) CEO MHRA) could see platform approvals as opposed to solely product approvals. JMHO.
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