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Sunday, July 18, 2021 2:46:29 PM
As for disclosing the analysis plan in their top line PR... are you joking? Remember, they've indicated it was phone book sized... how on earth could they disclose the SAP in their PR? They've already disclosed the endpoints in the last Q... and the same endpoints are already disclosed on the UK and EU trial sites. The journal is likely to closely follow the PR so no matter what they tell us in the PR, you'll know soon enough the details from the journal.
And I always love it when people suggest comparing the 33 who would be highly biased as anybody doing really bad would be excluded from cross-over.
I'm really not sure what you're trying to communicate with this statement. But to be clear... those 33 were part of this trial. Yes, they were very likely the patients who were to sick to cross over (I doubt they were "excluded"... they just may have been to sick to do it). If I were to guess at whether the primary comparison will include them... my guess would be no, and they'd just keep it to comparing the whole arms of the other trials (which will likely include their own sicker patients). Of course, those 33 will be included in the control arm that compares the randomized treatment to the randomized control of the DCVax trial. I don't think you're suggesting it should be otherwise, but heck, I'm just not clear on what you're saying with your statement above.
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