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Posted On: 07/03/2020 2:47:51 PM
Post# of 148902
a few questions, blafarm...
The blood work for the s/c trials is pretty simple (P:F, creatinine, platelets, bilirubin). Is Dr P processing the samples? If so, how would he tell which patients belong to which arm from this information? If not possible, do you suppose he is doing other tests on the sly? If he is doing tests on the sly, do you suppose he is discussing the results with CYDY?
If SAEs are reported to the sponsor (CYDY), do you suppose they are discussing specifics with the outsider, Dr P (who would have to be doing be doing additional assays on the sly and be willing to talk about it), to try to get an sneak peak at results?
My impression of the 50 patient interim look was always that it was a possibility rather than a definite, and:
I've heard that and surmised that, but have we actually heard anything unambiguous like that from NP? I'm dubious.
My working hypothesis is that Dr P is not doing anything with the s/c trials and is not in a position to know the mortality figures for the placebo and leronlimab arms. Also, CYDY would not call on him for statistical advice.
Instead, NP does not know the mortality distribution among groups, sees enrollment progressing nicely (along with the statistical power), and sees no need for a weak interim analysis.
At an earlier call where he talked about the possibility of interim analysis, he sounded defensive after hearing much criticism about the pace of enrollment [my dramatized recollection]: "No...although we've only added one or two patients in the past week, there's nothing to worry about on the enrollment front. We have enough patients to do interim analysis at any time." Reading between the lines, I saw an air of desperation: "Enrollment has been so slow that a piddly improvement in statistical power would not justify a further delay. Have no fear; the chemical is great and will show good results even in an underpowered test!" Now, with recruitment on a dramatic upswing (apparently), he is able to say, "Recruitment is going great, so a delay does indeed give us greater statistical power. Be patient."
The blood work for the s/c trials is pretty simple (P:F, creatinine, platelets, bilirubin). Is Dr P processing the samples? If so, how would he tell which patients belong to which arm from this information? If not possible, do you suppose he is doing other tests on the sly? If he is doing tests on the sly, do you suppose he is discussing the results with CYDY?
If SAEs are reported to the sponsor (CYDY), do you suppose they are discussing specifics with the outsider, Dr P (who would have to be doing be doing additional assays on the sly and be willing to talk about it), to try to get an sneak peak at results?
My impression of the 50 patient interim look was always that it was a possibility rather than a definite, and:
Quote:
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?
I've heard that and surmised that, but have we actually heard anything unambiguous like that from NP? I'm dubious.
My working hypothesis is that Dr P is not doing anything with the s/c trials and is not in a position to know the mortality figures for the placebo and leronlimab arms. Also, CYDY would not call on him for statistical advice.
Instead, NP does not know the mortality distribution among groups, sees enrollment progressing nicely (along with the statistical power), and sees no need for a weak interim analysis.
At an earlier call where he talked about the possibility of interim analysis, he sounded defensive after hearing much criticism about the pace of enrollment [my dramatized recollection]: "No...although we've only added one or two patients in the past week, there's nothing to worry about on the enrollment front. We have enough patients to do interim analysis at any time." Reading between the lines, I saw an air of desperation: "Enrollment has been so slow that a piddly improvement in statistical power would not justify a further delay. Have no fear; the chemical is great and will show good results even in an underpowered test!" Now, with recruitment on a dramatic upswing (apparently), he is able to say, "Recruitment is going great, so a delay does indeed give us greater statistical power. Be patient."
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