Thursday, December 28, 2023 11:04:44 PM
As far as I'm concerned, far more products should be made available sooner under EUA's, then followed with full approval. Had this been done with DCVax-L I suspect an EUA could have been issued back when the trial was halted and the goals were being changed to OS. Everyone who receives the vaccine under an EUA should have results reported in a Phase 4. Had that been done, I believe the Phase 4 data would have led to a tumor agnostic label, and approval some time ago if the company, manufacturing manually, could keep up with demand. Under an EUA they'd be entitled to be paid by insurance, I would suspect that the price could be higher after full approval, but the company would have had real earnings, especially if the EUA was internationally accepted.
Happy New Year's,
Gary
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