I believe as long as approval is still anticipated nothing needs to be said. If the regulators told the company their filing was going to be rejected officially, but they could appeal, I believe that would have to be revealed by the company.
The fact that nothing like that has ever been reported is good reason to believe we're still moving toward approval.
For all we know, the company may be fighting to get a much-expanded label, it's a fight they may lose, and we'll not know, but if we were to get that label, I suspect we'd be right in thinking it's why it took so long.
I believe it's been two years since we had a booth at ASCO, but I still remember the booth. It featured tumor agnostic all over the booth. The only way they could have possibly fought for such a label would be with anecdotal information from compassionate use, that's information that's never been displayed publicly to my knowledge, but it should exist somewhere and perhaps needed to be compiled. Anecdotal evidence is far from trial evidence as the protocol isn't specified, but I don't know that it could be ignored if for instance 10 pancreatic cancer patients received the vaccine and say 7 of them are still alive after a minimum of 3 years. It would be even more impressive if half these patients were ineligible for the Whipple procedure, but sufficient tumor could be removed to make the vaccine. I'm not saying that this is the case, only that if it were, I believe it would be wrong on the part of the regulators to not grant a more inclusive label but insist on a confirmational trial to prove their decision correct.
Gary
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