Monday, March 02, 2020 10:06:21 PM
. The author is clearly confused on the facts of the trial as the Nov 2018 data was not an IA.
. The author does not understand the table he posted where he clips .0151 as the OBF stopping rule. That is for 3 equally spaced analysis (i.e., 81,163,244 PFS) which was never the design. And no matter what they might have changed the design to behind the scenes, Nov 2018 was past 2/3 of any possible final.
. His blurb about crossover is total BS. You and I disagree on the possibility of any analysis to factor it out for a BLA/MMA, but whatever they do the math is developed and it is only a calculation. And not one that involves solving differential equations. Crossover is an issue for OS, but nothing novel.
. There is no need for NWBO to run a trial against or in combo with TTF. If TTF was SOC, this would be a valid point. If things play out well for NWBO then somebody will run the combo trial, but that means nothing for the near/mid term.
. His blurb where he lists the HR of Stupp/TTF/DCVax-L has issues. Either he fails to understand that HR is a comparison, or he he being very disingenuous as Stupp is compared to pre-Stupp while the other 2 are compared to Stupp. An apples to apples would have Stupp at 1.0
One point that happens to be correct is that if the OS curves really do separate as many longs hope, the trial would already be highly stat sig. It is fair to question why the trial is still ongoing.
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