Doc Logic, I wish I could hone in better. I do not claim to think I know the cause, but, just keep trying to tease out options to see what seems to fit the best. This protracted time frame is perplexing. If it is a mfg issue, why did they continue to enroll? I believe they are close to full enrollment due to the size of their clinical study network. For that matter a continuation of enrollment seems to rule out most negative issues and frankly most issues of any kind. The screening halt seems like a benign step. But, it has some meaning or else the company would have announced full enrollment when achieved. So, it is not fully enrolled. But a hold this long seems to rule out re-balancing also unless they are saving those last number of patients while the real issue is still worked out and they can then determine what type of patient to enroll. I think this is unlikely given this amount of time. I have to conclude that the best clue when LP stated in so many words that this was a positive event for the study. I am back to square one and believe it was caused by an IA and ensuing dialogue with regulatory bodies, which led to a question about the data, which required additional data submissions to regulatory bodies. If regulatory bodies had questions about which patients received product from which manufacturing process to be sure there was no therapeutic difference caused by a change in the mfg process, then, maybe there could be a mfg related question. But, that seems remote and should not take so long to determine. So, my belief is what it was in the very beginning: an IA (for efficacy due to a significant number or patients doing surprisingly well) caused the hold but the median PFS needed more events for statistical strength and OS was showing few events, also requiring more events. When they speak of providing additional data to regulatory bodies I think they are just submitting updated patient data on PFS and OS. I do not think they will be enrolling more patients but are waiting for PFS and OS events and/or for the OS data to show statistically that patients benefit from treatment either way, initially or post progression. NWBO is obviously still blinded.
