IMHO, the biggest singular hurdle that needs to be overcome, is whether or not, this retrospective amalgamation of swept up data, from past disparate P1/2 Trials, will even pass the MHRA Phase. 3 bar, ?
To remove all efficacy doubts, it would be wholly reasonable for the Regulators to insist on a fresh UK Only based, externally monitored new Phase 3 Clinical Trial.
They will certainly insist on more than the, now meaningless, primary generic diagnosis of ‘GBM4. as the singular metric for inclusion.
As it stands, there are way more Regulatory questions than answers.
Which is never a good thing for an Applicant.