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flipper44

04/25/17 5:17 PM

#115141 RE: Evaluate #115126

1. Pyrr's comment relates to an allegation that there was a failed futility (not an efficacy) analysis around 160+ events. I don't think he can say anything with complete objective certainty about that without very material information that the public does not have. If he is speculating, he should have said that. For Les to indicate they are blinded and do not know the results for the primary endpoint, does not completely disprove that, because, as you know, even the public in some trials can learn about DMC recommendations for example, and yet the trial remains blinded. Here, Pyrr is saying the trial was so futile back around 160+ events, that it was "certainly" going to fail -- no if and or buts according to him. I don't know how on earth he could be objectively certain about that without information the public does not have -- so I assume he is speculating even though he did not present it as speculation. I don't know how, if that would have been the reason for the partial clinical halt, the clinical hold on screening would have been lifted. Nothing makes sense, but to answer your question, no, you can't prove Pyrr's claim completely false simply because the company remains blinded and doesn't know if the trail succeeded or failed, but there are many clues suggesting that it might be the case. It would make it very hard to know there was complete futility unless the company and agencies were unblinded, and Les states the company is still blinded.

2. Les said the company would know when they reached 233 events. I don't know if they get patient by patient updates on OS, but we've been through this before with "well over." With OS, "well over" meant 31 beyond 300 (the highest it could have been without knowing at the time was 348, so 331 definitely constituted "well over.") They certainly knew the approximate number and expected rate in February 2017 for OS, and Les seemed to be speaking with that knowledge in mind.