I'll admit to lazily picking a date that was in the middle of a range posted by someone else, if T-42 is more correct, I'm happy to go with that. I also wasn't the one to discover the earlier goal the UK indicated they'd target to, but have referred to it enough that people are crediting me for finding it. If T-42 is the correct date, but T-30 is the new target date, that would be saying we're 12 days from the targeted decision date. That too sounds great to me.
Many here were very critical of the company when they missed on making their initial filing date, than even more criticism when it was further delayed. I believe it's very possible that the reason we're not seeing RFI's now is because of the changes that were made then. I believe that NWBO has been working closely with all four regulators all along and no doubt that has resulted in substantial delay as changes made awaited the acceptance of all four regulators. If one regulator wanted a change, I don't believe they proceeded until all four agreed to whatever the change was. Clearly it takes much longer to get 4 agencies all agreeing to the same thing, but I believe the payoff will come now as approval of DCVax-L will fly through the UK, and through the others as all terms they want in place are ready as well.
It's my belief that adequate commercial production is available, it can come from either the acceptance of the EDEN or substantial expansion of manual production capability at Sawston, and perhaps elsewhere. I'm unsure that the FDA may not require production capability within the US. The company may not speak about their plans frequently, and there are some things that cannot be announced until some preceding event occurs, but they have planned well for the future, and we'll all be well rewarded as they proceed with their plan.
I'll predict that once the UK approval is announced, then the Annual Meeting will be, and then we'll get at least some of the future guidance we've been eager to hear. I would expect that once again we'll appear at the Expert's Theater at ASCO, and perhaps there is a possibility that UCLA will be presenting info on their trials that add Poly-ICLC and/or Keytruda to DCVax-L in a peer reviewed presentation. Clearly it's an early stage trial, but with approval of DCVax-L in the UK anticipated UCLA may have considered the submission of an Abstract. If not, perhaps at one of the other major conferences later in the year.
Gary
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