I respectfully disagree with this statement.Quote:They don't know the distribution of deaths between the two arms...
I think Dr.BP knows exactly which patients are in the leronlimab arm and which are in the placebo arm.
Multiple sources experienced with clinical trials have suggested that each patient is issued a static ID number for all lab tests. Those individuals have indicated that the ID numbers are not randomized for each blood sample.
Dr.BP's specifically designed companion assays very likely show the presence of the leronlimab molecule in blood samples. However, failing that, the dramatic positive shift in several metrics seen in even the sickest patients (Montefiore), must indicate who is in the treatment arm and who is in the placebo arm.
Finally, because the patients each have static ID numbers, if Dr.BP stops receiving blood samples for any specific patient, then that patient has (unfortunately) passed away.
In addition to that, it is a fact that death qualifies as an SAE (Serious Adverse Event), and that event is reported by the Lead Investigator to the trial Sponsor using the same ID number. The Sponsor is CytoDyn.
So I have to believe it is a trivial matter for CytoDyn, in conjunction with Dr.BP, to know precisely how a trial with a largely binary primary endpoint (Death at Day 28) is proceeding.
I don't know how to "read" Dr.NP's "many deaths" comment in that video. It was certainly a comment that could have been handled better, from a variety of standpoints.
I also admit to not understanding the forces at-play that have transformed what we have been told for months as being a definite 50-patient interim look -- to -- "if the FDA lets us".
How many times have we been told that the selection of the May 31 cutoff (S/C) and the June 15 cutoff (M/M) were entirely orchestrated to synchronize those respective readouts for presentation to the FDA at some time shortly after July 1?
How did this change, and why were we told (so many times) such imperfect information? We are now left scrambling to guess if the interim look will occur at 100 or 120 -- or if we just have to finish the entire 390.
Is this bus being driven by the FDA ("if the FDA lets us)? Or is this a byproduct of a perceived statistical shortcomings seen by Dr.BP? I don't know.
What I do know is that there needs to be a substantial overall improvement in the dissemination of clear and concise of information to shareholders. And that transformation needs to happen before CytoDyn finds itself in the glaring spotlight of COVID approval, and before it is scrutinized by a class of institutional investors that will arrive as a byproduct of having been uplisted.
Even if the net effect of this transformation is that we, as shareholders, get less information, it is critically important for the credibility of the company. I spend a lot of time listening to quarterly earnings calls held by other biotechs and I can tell you that CytoDyn is going to have to make some dramatic changes. I really hope they understand that -- but I fear they don't.
Lastly, please don't take this as a criticism of Dr.NP. I have nothing but respect and admiration for him. I am repeatedly blown away by his diplomacy, tenacity and compassion. And hearing how this CEO personally gets involved with sick and dying people who desperately need to gain access to the molecule makes me want to nominate him for "Person of the Year".
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