Outstanding interview of Dr.BP by Dr.Yo on his YouTube channel.
I would characterize it as required viewing.
Rumors and conjecture aside, it is crystal clear that Dr.BP remains an enormous advocate of leronlimab, and is very motivated to continue collaborating with the company on many critically important levels.
His companion assays, testing kits, cancer white paper, and further deep investigations into the molecule and its MOA, provide conclusive evidence that he is fully onboard.
Watching that video really made me feel good.
Video Link: https://www.youtube.com/watch?v=m-QwvDlF4UU&a...e=youtu.be
Lastly, regarding the topic of the number of deaths in the P3 S/C, as Dr.BP mentioned, there is a sad requirement for a high number in order to achieve statistical significance.
It is worth remembering that on June 11th we were told that Dr. Otto Yang (UCLA) and Dr. Seethamraju (Montefiore) participated in a phone call with the FDA requesting a relaxation of the Inclusion Criteria to include intubated patients. Prior to that call, intubated patients were excluded.
The number of subjects enrolled in the S/C on June 11 was 51. And we have been told that the DSMC will be looking at 100 subjects for the safety review this week.
Whether or not that 100 number was able to be incrementally increased due to the 1-2 weeks of elapsed time between hearing that number, and the investigation this week -- or whether it remains at 100 due to a possible cutoff that maybe occurred a week or two ago due to the requirement to lock certain databases in advance of the review -- is unknown.
However, I think it is reasonable to assume that individuals who have been intubated have a higher probability of mortality. So, it is conceivable that our 100 subject sample is maybe divided equally between patients that were not allowed to be intubated, and patients that were allowed to be intubated (obviously, not all of them were).
Over the past month, I have spent many hours considering the potential ramifications of this protocol change on our S/C trial, and wondering if the DSMC results would be more skewed in our favor had intubated patients been allowed from the inception.
I guess there are two ways of looking at it:
- A protocol that excluded intubated patients might yield very few (and maybe close to zero) deaths in the treatment arm -- while there would still be deaths in the placebo arm. Hopefully, the results would be statistically significant.
- A protocol that allowed intubated patients might yield a greater number of deaths in both arms -- but maybe an outsize number in the placebo arm. Again, hopefully the results would be statistically significant.
There's nothing we can do about it now. My conclusion is that we have a somewhat blended cohort in the 50/50 split, and there's no way to knowing exactly how many intubated subjects were enrolled after the protocol change was made on June 11.
I would characterize it as required viewing.
Rumors and conjecture aside, it is crystal clear that Dr.BP remains an enormous advocate of leronlimab, and is very motivated to continue collaborating with the company on many critically important levels.
His companion assays, testing kits, cancer white paper, and further deep investigations into the molecule and its MOA, provide conclusive evidence that he is fully onboard.
Watching that video really made me feel good.
Video Link: https://www.youtube.com/watch?v=m-QwvDlF4UU&a...e=youtu.be
Lastly, regarding the topic of the number of deaths in the P3 S/C, as Dr.BP mentioned, there is a sad requirement for a high number in order to achieve statistical significance.
It is worth remembering that on June 11th we were told that Dr. Otto Yang (UCLA) and Dr. Seethamraju (Montefiore) participated in a phone call with the FDA requesting a relaxation of the Inclusion Criteria to include intubated patients. Prior to that call, intubated patients were excluded.
The number of subjects enrolled in the S/C on June 11 was 51. And we have been told that the DSMC will be looking at 100 subjects for the safety review this week.
Whether or not that 100 number was able to be incrementally increased due to the 1-2 weeks of elapsed time between hearing that number, and the investigation this week -- or whether it remains at 100 due to a possible cutoff that maybe occurred a week or two ago due to the requirement to lock certain databases in advance of the review -- is unknown.
However, I think it is reasonable to assume that individuals who have been intubated have a higher probability of mortality. So, it is conceivable that our 100 subject sample is maybe divided equally between patients that were not allowed to be intubated, and patients that were allowed to be intubated (obviously, not all of them were).
Over the past month, I have spent many hours considering the potential ramifications of this protocol change on our S/C trial, and wondering if the DSMC results would be more skewed in our favor had intubated patients been allowed from the inception.
I guess there are two ways of looking at it:
- A protocol that excluded intubated patients might yield very few (and maybe close to zero) deaths in the treatment arm -- while there would still be deaths in the placebo arm. Hopefully, the results would be statistically significant.
- A protocol that allowed intubated patients might yield a greater number of deaths in both arms -- but maybe an outsize number in the placebo arm. Again, hopefully the results would be statistically significant.
There's nothing we can do about it now. My conclusion is that we have a somewhat blended cohort in the 50/50 split, and there's no way to knowing exactly how many intubated subjects were enrolled after the protocol change was made on June 11.
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