Flipper and Senti, can you help me with my thinking? I'm trying to get a handle on where we stand.
Let's assume an interim review has occurred. A stop for futility or safety is ruled out because the trial and treatment is continuing. If the DMC's recommendation was for the trial to continue, does NWBO have a legal obligation to PR that? Even if there was no legal obligation, I'm not sure why they would not choose to update us with a PR. There is no dancing around that fact and doesn't affect the company negatively. So it seems like the only other outcome is likely a DMC recommendation of early halt for efficacy.
Now, FDA guidelines suggest that the company engage in a dialogue with the FDA with regards to such a recommendation from a DMC before deciding to halt the trial. Obviously, the data cannot be unblinded. Is it possible for the FDA to talk directly with the DMC and the statistician (with no intermediation by NWBO staff) to get a better handle on the data before they can give some guidance to NWBO about whether or not they encourage an early/rolling filing ? It seems like NWBO has already submitted trial information such as enrollment numbers, etc. and this was probably done about 6 weeks ago (a week after the last PR). But I'm pretty sure the FDA will need more than that to provide guidance on how to move forward, which was the reason for my earlier question about direct contact with DMC and the statistician.
Secondly, is it possible that the FDA could accept an early filing with the caveat that the remaining 48 or so participants will need to be enrolled (concurrently with the rolling filing) before the FDA issues a decision? Is this what the discussion with the FDA would entail? Is this what the company is waiting for, before we hear from them?
Finally, the reason for the screening halt is still a big mystery to me. If it is, as we assumed, for cost reasons, then an interim halt is still very much in play. Because if the halt was the company's discretion, then any indication from the FDA that the trial will need to fully enroll would have made them lift the screening halt by now. I just can't imagine why any regulator would halt screening but allow treatment to continue.
Many thanks for your help.
