I agree that we don't know what the p value adjusted criteria are for halting at the separate IAs. After long deliberation, I agree with you that if a halt is recommended at one of the IAs that it will be announced. I'm of course less certain regarding how they intend to go about their specific accelerated approval were that to become available, but I think that the new post trial blinded clause is likely.
Regarding the late IA, I see this as positive....patients are likely living longer. Also, there is no question the data gets to mature more under the current event trigger number. Before the resizing, the placebo group was set to enroll more patients (104) than the number of events required (66) for the first IA. Now the 1st interim event trigger number (149) is more than the total anticipated number of placebo patients (116). This forces/ensures a larger number of events from the treatment group must occur before the first interim analysis. This means the median PFS for the treatment group will not be exceedingly far off by by the time a potential halt or completion occurs in order that the time between potential halt/completion and actual accelerated approval at least gives the treatment group a chance to obtain a median PFS.
Regarding the trend toward faster clinic openings this year than past years, I see that as a somewhat expected phenomenon for small biotech companies, prior interference by AF, new financial backing, and I think Dr. Bosch's recent presentation in Germany will go a long way toward completing enrollment, particularly in Germany.
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