RE:RE:RE:RE:EDT BB, 5% and 18% MB is all we have! MM, I have now changed my mind on the 45%. I have gone over the filed Sedar docs and their two last powerpoints (July and R&R conference). If we only look at the hard numbers provided in filed documents, and even the "45% CM for all randomized patiens", it appears to me far more logical that the 45% is actually for "all randomized patients".
At the interim analysis, their numbers were certainly not that good if they decided to increase the number of patients to be enrolled.
Then, later on, if they decided to only look at MODS >9 patients, where they had in their view a better chance at proving a significant improvement, it was also a sign that their numbers were not already that satisfactory.
They started with a CM of around 30%. When they changed the protocol to only look at MODS >9 patients, it climmed up to 50%. There is a problem around that point with the numbers, I think SWYG alluded to it, although in his always mysterious ways. But still, there is a direction. Since the trial continued on with sickers patients, logic would point to and increased CM in the narrower patient population, climbing somewhere towards 60%, as they stated they had with the non-consent patient population. And if we combine all randomized patients (446), we could very well have an overall CM of around 45%. So no magic placebo effect.
Where we were scrwd was in all the open language used to declare the happiness, and excitement, and "if you do the math", and "very significant", which are a lot harder to use to go after them in an official manner.
The one number they could get clobbered with is the 243 (if I recall) in the infamous "failed trial" NR. That was a very big no no in my mind. They had no right to use that number to disclose the results of their trial, unless they qualified it, such as, we were around 5% with the 176 patients agreed to, so we used some from the extended use program, and still, it remained at 5%. But the way they announced it, it was like Walker was nowhere to be found and they threw some numbers without any consideration for the public and the retail shareholders.
All the other hints they gave us are weak circumstantial evidence, or it could be argued in court that they are.
So imagine what I think about the 18% MB for some... for who, blue-eyed left-handed teenagers?
I am more than ever appauled by the infinite difference in knowledge status that exists between insiders and outsiders.
And to conclude, we were often reminded on this board that we could also count on the EUPHAS trial and the registry that was compiled in Italy using the same population criteria. Well, that trial was for a specific population, for abdominal sepsis patients. They got a very good 21% MB over a 43% CM. Doesn't that number remind us of the 45% CM for all randomized patients? They did say sicker patients were even more to benefit, but how much? Mystery.
So for me, 45% is not for the 176 patients. And there is no significant placebo effect. the only string not attached for me in this unified theory of the Universe, is why their AMB was only 5% in their preferred population. Better SOC in America? Some other factor? Who knows.