Thanks for your reply. I do agree that fast enrollment is a positive sign of the interest in the public for this trial, but I'm not so sure about whether it is a good predictor of success. I do consider the management's comments regarding the slower than anticipated OS events accruing as a potential red flag along with their plans of changing the SAP in a SPA approved trial ESPECIALLY considering that this trial is open labeled. I'd be a little cautious on VB-111's chances of reproducing the p2 trial results. The logic is that IF the slower than expected OS eventing is due to the combo arm in this OPEN labeled trial, then just stick to the original SAP because the chances of success is even higher with no need to tweak it. But IF the reason is due to the ctrl arm not eventing as fast, then there is a problem of needing to increase the number of events to properly power the trial for evaluation. To be safe, I'd pick the latter alternative unless the company can give a better explanation why they are seeking these changes. Depending on how the FDA responds to this request, this proposal can be viewed either positively or negatively. I expect the FDA to reject this proposal due to the potential bias from an open labeled nature of this pivotal trial. If they accept, then I'd be more prone to believe that the reason is due solely to faster recruitment.
JMHO
