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Avii is right biosectinvestor... there was a safety

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sentiment_stocks Member Level  Tuesday, 06/11/19 11:55:56 AM
Re: biosectinvestor post# 232508
Post # of 237068 
Avii is right biosectinvestor... there was a safety analysis done, in late 2013. They planned to do an efficacy one soon after, but instead, opted to increase the trial size and held off.

But as Avii pointed out in the slide, there was an efficacy analysis IA intended for sometime in the summer of 2015. I believe they opted not to do it. I think they suspected something was not correct with what the blinded data was showing with regards to PFS... and they opted to not unblind while they figured that out. I think there were a myriad of things they suspected, including that someone(s) was messing or hacking into the data and changing it. I think they eventually ruled out everything but... what the journal fully stated, and that is that pseudo progression can wreak havoc with a trial. And so, they marched forward with the other "independently powered endpoint" OS, as that was the only good choice they had to save the trial.

All my opinion, of course, but I think it's it's a pretty damn good one.

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