Keep your eye on the ball. In the UK we need DCVax-l approval for GMP EDEN testing parallel to commercial artisan. That really really needs to happen. However, with the FDA, well what would bypass all this patient level data back and forth? Keep your eye on the combo trial primary completion date moved to December 1, 2024. Remember what I cited many years ago, that a confirmation trial, even testing in different indications, or in this case, adding a combo or not, could/should be significantly initiated prior to original approval on the main trial.
From LP’s recent ASM out of the blue comments about using surrogates again, (and from that interim survival chart a couple years ago) it looks like the combo trial experimental arm won out.
That was a placebo controlled trial, and as I’ve mentioned before, and cited recently, the FDA will move on convincing phase I data in orphan indications, in this case backed up by a 15 year phase iii trial. So add to that, after UK approval initially without the combo, immediately followed by combo trial unveiling, immediately followed by joint FDA EMA applications by ??? Which by then can include EDEN as the proposed commercial manufacturing mode, all surrounded by increasing pent up demand, etc.
LP is talking about surrogates again, UCLA and Merck are trying not to front run UK decision but plan on combo results following on heels of UK decision, LP is now waiting to file applications which she before was saying would simply be carbon copies. It seems more like NWBO and Merck are dancing and obviously trying not to step on each others’ toes.
JMHO.
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