By "squishy", I mean that CD12 primary endpoint comes in
By "squishy", I mean that CD12 primary endpoint comes in with something on the order of 20-25% mortality reduction and a p-value of 0.1 or so.
These numbers would constitute a primary endpoint fail.
It seems to me like the covid treatment landscape is chaotic. Severe/Critical/ICU mortality rates seem to have a very wide range at different hospitals which is likely due not only to the capability/conditions of the hospitality but also due to the different populations that the hospitals treat.
The wide range of outcomes at different hospitals suggests to me that covid mortality is so multifactorial that anything can happen in CD12.
For example, Dr. Agresti had four patients all of whom responded well to LL but half of whom died from other factors after the covid infection was controlled. These patients are medically fragile in a wide variety of different ways.
Some Montefiore patients similarly died from lack of medical resources.
In the event of a primary endpoint fail, the FDA reviewers well look at secondary endpoints and any other argument CYDY cares to offer.
If memory serves, remdesiver was offered EUA upon the outcome of an interim analysis. Furthermore, remdesivir failed its primary endpoint but passed a secondary endpoint. I believe the Eli Lilly covid mab experienced a simialar event during its path to EUA. The Eli Lilly primary endpoint failed, but a secondary endpoint passed. I think the Eli Lilly mab was at the end of its Phase 3 and not at an interim but I dont really remember.
So it seems to me that a miss on the CD12 primary endpoint will be followed by an examination of the other evidence that might be available.
If the RO data was available, that would be good.
If you look at Patterson's journal paper on the Montefiore patients, CCR5 RO graphs indicate a more robust response than any other parameter. Viremia and CD8 counts look better than others, but only the CCR5 RO is robust for every patient.
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