Drilling down further on the EXCEED idea...If I was in Mgt shoes, knowing what they know about gut translocation and endotoxemia, the 21% effiency in the non- culturable bacteria subgroup and Euphas 1 (trial stoppage stats) and the Euphas 2 registry...
with careful patient selection, I would be expecting 21 % absolute mortality benefit.
If Tigris were to "exceed" my expectations, I would think that the Tigris group would be running somewhere in the high 20's (or better?).
Knowing that the Tigris results are weighted 100% vs Euphrates at 75%
And playing around with my calculator...
Lets assume 40 patients in Tigris within a few months (running with an absolute benefit of 29%). After applying the appropriate weighting and considering that the Trial at that point would be about 2/3rds completed in terms of # patients in the combined Trial (179+40)/(179+150) or 219/329 = 66%....
I get a running absolute overall benefit of somewhere around 15 % (assuming 40 Tigris patients, "exceeding" expectations")
Wondering if the FDA thinks (for an Open Label Trial trying to confirm 10%) that the Trial should go the full 150, IF after 2/3rds of the patients (179+40) they are running at 15 % AB ? Especially if the FDA has heard that Covid-19 often leads to Sepsis (gram negative bacteria escaping into the bloodstream through intestinal walls, leading to endotoxemia, MOF and death)
Check my math someone please.
Not convinced? How about 20% AB after 80-90 (and 80% completion in terms of 329 total patients) ? Do we really need to see more confirmationally speaking? How about statistically speaking? at the risk of 10's of thousands more dying?
Statisticians are fun and all (especially at cocktail parties) but do we really want to put them in charge when it comes down to life and death situations?
I submit that (if it is true that Tigris is EXCEEDING expectations, by a comfortable margin, there is a magic number of Tigris patients (possibly between 40 and 90) that results in this Trial ending with an immediate approval for PMX. And if so, then the reverse of Oct 2016 happens....all of a sudden, and possibly without any warning. That would be a good time for S to ask B to sharpen it's pencil.
DYODD and DCYM (double check your math).
MM