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meirluc

01/29/22 7:26 PM

#439695 RE: meirluc #439693

edit: (32.6% of the trial)
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biosectinvestor

01/29/22 7:53 PM

#439704 RE: meirluc #439693

They did not just put a group in one arm or the other. But at the end of the day, one arm that was supposed to all be placebo, apparently was not placebo. That maintains the blind, until unblinding.

If they had messed up the randomization as badly some are suggesting, that would be an entirely different problem, and a serious one.

Post was restored, too late to edit.
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sentiment_stocks

01/29/22 8:17 PM

#439707 RE: meirluc #439693

We agree that the longer living patients in the later part of the trial that you and I both played a part in carefully measuring is ... interesting, and highly coincidental, given that the treatment arm was enrolled to its exact number, while the control arm was not. I also thought for a time that this was evidence that the control arm had been crossed over to treatment.

I have not thought this, however, for several years now. In fact, I even argued against submitted that question back in 2019 because I felt is was a complete waste of a question. Maybe it wasn't a waste, though, because I can point back to Les' answer when it comes up.

Remember too that we thought perhaps they had completed equivalency testing on type of manufacturing used to create Direct (I can't remember its name right now, but there are a hundred people on this board who do) and had begun using it midway through the trial (even their SEC filings had suggested this, for a time, until they dropped it). But there is no mention of this in the JTM article, so I doubt that was what caused it.

Flipper has suggested that perhaps the stuff that makes the tumor turn pink (5-ALA / 5-aminolevulinic acid) when surgery is done may have helped the surgeons to make a more complete removal of the tumor could have contributed to the improved survival. While this was not approved in the US until 2017, I think it was approved in Europe sooner... and I think we thought a good many of the later enrolled patients came from the UK, Germany and Canada. Anyhow... I don't know why the later group had a higher survival rate... but I agree that the data indicates that they did.
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newman2021

01/29/22 9:28 PM

#439714 RE: meirluc #439693

superior question indeed! Interesting if overrepresentation!!