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Saturday, January 29, 2022 8:17:05 PM
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.
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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