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flipper44

06/17/18 3:26 PM

#178382 RE: longfellow95 #178378

By November 2016, 99% placebo likely PFS progressed. Straight away, if you read the December 2016 chart fairly, it's 100%. However, with .4% possibly eventing by March 2017, it's possible to keep the blind honest as it might be interpreted as only 99%. Way back in the day, Exwannabe made the comment that if the December 2016 chart was 100%, then everyone who had not evented by December 2016 would know they were on treatment. Get it? So Dr. Bosch comes along in June 2017 and states, oh ya know, it's "nearly 90%," and we all basically thought, "oh well, more placebo had pfs evented, so the chart from December 2016 must have been wrong," and more were placebo PFS evented, but as we now see in the May 2018 publication, the December 2016 chart was not wrong, and there were still 86% (+ perhaps .4%) in March 2017, which according to the chart makes sense) and the researchers and everyone were saying 86.4% is nearly 90%, but it really isn't. Thus the blind was being kept alive for that last 83 ( - perhaps 30 that were not randomized at the very end of enrollment) or so patients by .4% after November 2016.

I snapped at DGDW because I'm tired of him launching direct and indirect attacks at Dr. Liau. What DGDW likely has not considered is who was Dr. Liau's real intended audience that day, and I'm thinking it was the regulators. The regulators that likely had 83 data points placed in their face telling them the partial screening hold was ill founded. Dr. Liau likely saved the trial that day. She has no financial ties to the company.

It's time to unblind the trial because for eleven years, ELEVEN YEARS, no matter what year a group was enrolled into the trial, it did not impact the trial efficacy curve (except perhaps the last 30 enrolled in the last year because they were likely not randomized.) There are people that need this treatment (if it is successful) and do not want to wear the electric helmet (from an unblinded no placebo trial). LP's argument that the trial tail KM curve will somehow get thicker is not logical (aside from perhaps the last nonrandomized 30 or so patients). Why? Because her own researchers state there is "no meaningful" variance in single arm efficacy from year to year -- of ELEVEN YEARS!

LP has the shipping news (which does not technically unblind the trial), and it is good. Unblind the trial (at the very latest by the end of this refresh).