It's not a single treatment. It's an ongoing treatment for patients that are sick. In this case, if the FDA actually thought it sped the recurrence of cancer enough to halt on that basis, that would be a SAFETY ISSUE. A halt on that basis suggests that the FDA thinks the vaccine is making people sicker faster. They continued enrolling patients who had not yet received vaccine. Safety halts don't work that way.
Granted, the argument that they later convinced the FDA that what looked like PFS wasn't PFS and there was an OS benefit is very possibly an actual conversation that was being had across the trial, amongst many doctors and agencies, but if there was a halt on that basis, and it was not a "SAFETY" issue, I'd be deeply surprised.
I think the conversation was occurring, but I don't think they thought it was actual PFS. I think they had an idea that it was the vaccine working, and I don't think that was likely the cause of the halt. Possible, but not likely in my estimation.
Reasonable and appropriate scientific discussion and theory to be working through as the trial was proceeding, but an immune reaction was a premise of the treatment. So of course they'd expect an immune response and be looking for evidence of it from the very beginning. It's one reason some have also said, and I believe this is true, that DCVax-L is a little weaker, because you are operating within a skull, and causing a brain to swell too much is potentially dangerous. However, there were no indications that such events happened either, to a dangerous level. If it had, that would be a safety event the company would have had to have discussed.
I suspect the halt was for entirely different reasons, but even longs have given in to the non-stop drum beat of shorts, which of course show actual things and make it seem like those actual things are a bad thing... Over time, that was resolved into it could have been a problem... and now people may accept that as the likely cause of a halt. As I said, anything is possible, even that, but I don't think that is the likely cause of the halt, or there would not have likely been other arms, and humanitarian approvals that included people like Kat. The FDA doesn't work that way. They don't approve unsafe treatments for humanitarian care while halting a trial for safety and allowing patients to continue taking an agent that may cause recurrence of cancer. There would have been a very serious set of meetings and they'd have resolved that kind of a question long before last year. Long before.
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