Ok. There have been a number of responses questioning my last post. They may all be valid criticisms, and if I was wrong, I apologize to the board.
A while back I wrote:
However, I did couch my last post by saying:
However, I stand by my assertion that Dr.NP should be nominated for Person of the Year.
A while back I wrote:
I quickly received a response from CTMedic whose posts strongly suggest involvement in the medical field:Quote:I've been think about the probability of this happening, and the level of granularity that might be communicated by NP.
If the Day 28 death counts are disclosed, it would seem trivial for us to calculate the P-value.
However, what I don't know is how much the Secondary Outcome Measures (see below) can possibly influence the Primary Outcome Measures.
Question 1. Can those Secondaries 'tilt the scales' in a meaningful way?
Also, and I haven't posed this question to the board yet, but the Secondary Outcome of the S/C trial does NOT include Dr.BP's blood tests that are in the M/M protocol. I can imagine CytoDyn intentionally omitting that Secondary because Dr.BP may not have wanted to commit to performing those tests for the entire 390 subject trial.
Question 2. Do we think Dr.BP might have agreed to perform those tests for at least the first 50 interim subjects -- so that we could tell the whole efficacy story to the FDA?
I ask this because without Dr.BP's blood tests for the interim subjects, I think we have a harder time swaying the FDA on what exactly leronlimab does for that cohort of patients (as the EIND patient's blood tests are probably always going to be considered anecdotal).
I believe I received one or two other posts which confirmed that assumption, but I can't find them now. It is on that basis that I internalized that those blood tests were likely being conducted by Dr.BP on at least the interim P3 S/C patients.Quote:I find it improbable that Dr. BP would not conduct complete cytokine, RNA transcriptions, etc on severe/ critical patients. This was offered free for MIS-C /Kawasaki like disease manifestations in pediatric patients.
Dr BP and Incelldx appear to be glued at the hip to Cytodyn. I expect that he and his company will (appropriately) provide any analysis needed to keep this process moving forward.
The waiting is painful. I can only imagine how this must be for the longtime holders from the Pro 140 early HIV trial days.
As many others have said, be patient. Support cytodyn as they navigate the approval process and progression from a clinical stage company to a commercial stage one.
However, I did couch my last post by saying:
I made an assumption in my last post which could be completely inaccurate, which if true I regret.Quote:I think Dr.BP knows exactly which patients are in the leronlimab arm and which are in the placebo arm.
However, I stand by my assertion that Dr.NP should be nominated for Person of the Year.
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