Here's a thought that is apropos of nothing in par
Post# of 154816
(Total Views: 717)
Posted On: 07/01/2020 2:11:20 PM
Here's a thought that is apropos of nothing in particular.
Given what we have been told dozens of times, I've been operating with the understanding that we were submitting the first 50/51 patients of the P3 S/C as an interim result.
And based on the fact that those patients were enrolled before the June protocol change that relaxed the exclusion criteria (allowing patients in greater distress to join the trial), I've been assuming that the treatment arm would likely have zero deaths. I viewed this zero number as being beneficial to the P-value, probably impressing the FDA, and having superior optics in terms of the media and general public.
If we are not allowed to present that 50/51 patient interim result, or frankly if the FDA demands an incrementally larger sample (if not the entire 390), I anticipate there will be a much larger number of deaths in the treatment arm.
Of course, one could assume the placebo arm would increase as well. I just don't know if they would both increase on the same percentage basis. And I don't know if the inclusion of these more distressed patients, and the associated higher death rates in the treatment arm, will be viewed as being less impressive (kind of like our first Montefiore patients -- where we accomplished so much, but never really got credit for it due to the number of deaths of those very sick patients).
Given what we have been told dozens of times, I've been operating with the understanding that we were submitting the first 50/51 patients of the P3 S/C as an interim result.
And based on the fact that those patients were enrolled before the June protocol change that relaxed the exclusion criteria (allowing patients in greater distress to join the trial), I've been assuming that the treatment arm would likely have zero deaths. I viewed this zero number as being beneficial to the P-value, probably impressing the FDA, and having superior optics in terms of the media and general public.
If we are not allowed to present that 50/51 patient interim result, or frankly if the FDA demands an incrementally larger sample (if not the entire 390), I anticipate there will be a much larger number of deaths in the treatment arm.
Of course, one could assume the placebo arm would increase as well. I just don't know if they would both increase on the same percentage basis. And I don't know if the inclusion of these more distressed patients, and the associated higher death rates in the treatment arm, will be viewed as being less impressive (kind of like our first Montefiore patients -- where we accomplished so much, but never really got credit for it due to the number of deaths of those very sick patients).
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