I believe that your most recent posts are right on the money. The biggest question in my mind is the tumor agnostic label. If that's what's in debate, and if at the end they do authorize a tumor agnostic label, this approval will shock the entire industry.
I believe it's possible, but almost certainly it would require confirmational trials. The question there may be, would one omnibus trial, where many cancers were used in a single trial be permitted, or would numerous smaller trials be required on a variety of solid cancers.
Another possibility, which I'd love to see, is every patient receiving DCVax-L having their progress and outcome reported in a Phase 4. Any issues arrived at in the Phase 4 could require confirmational trials.
Regardless of how it's done, the EDEN approval would have to be part of the overall package as the demand for the vaccine would totally overwhelm the existing 20 tiny cleanrooms producing the DCVax-L.
Gary
Bullish
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