CYDY has ALWAYS BEEN UNBLINDED on CD12?!?!?!?
That post is way beyond an "interesting read".
That post is an unequivocal claim that CYDY has always known the results of the CD12 trial in real time as they have developed.
If true, every comment and action by Pourhassan must be re-examined in light of the possiblity that Pourhassan and possibly every other CYDY employee knows the CD12 primary endpoint progress and has known this progress from the first day the first CD12 patient was dosed.
"Knowing the results" is not quite the same thing as "unblinded", but as a practical matter there absolutely is no difference if I am a CYDY employee who wants to know how CD12 is progressing.
There are only three predicates, the first two claimed by Science+Compliance as facts, upon which the claim that CYDY has always known real-time CD12 results:
1) A file named eTMF exists and that file includes the medical records of CD12 patients.
2) Someone at CYDY can open that file and review the medical records.
3) Pourhassan elected to review the eTMF file and the CD12 results it provides.
Can anyone comment on whether these predicates are possible? Is there really such thing as an eTMF file? Does it include all of the CD12 patient medical records, including blood test results?
Finally, and most importantly, who at CYDY is allowed to access the eTMF and are they allowed to publicly reveal what they learned from the eTMF?
A serious deficit in Science+Compliance's analysis is that he does not understand leronlimab and CCR5.
CCR5 receptor occupancy, which is performed on all CD12 patients, distinguishes between leronlimab and placebo arms with 100% accuracy. Science+Compliance discusses RANTES, bilirubin and others in the context of whether or not the medical records can indicate LL or placebo, but none of those are relevant. CCR5 receptor occupancy is 100% dispositiv of who got LL and who is on placebo.
So if there exists an electronic file that contains medical records for all CD12 patients, and if that file is accessible to CYDY employees, then anyone at CYDY interested to look can see the CD12 progress in real time.
That post is way beyond an "interesting read".
That post is an unequivocal claim that CYDY has always known the results of the CD12 trial in real time as they have developed.
If true, every comment and action by Pourhassan must be re-examined in light of the possiblity that Pourhassan and possibly every other CYDY employee knows the CD12 primary endpoint progress and has known this progress from the first day the first CD12 patient was dosed.
"Knowing the results" is not quite the same thing as "unblinded", but as a practical matter there absolutely is no difference if I am a CYDY employee who wants to know how CD12 is progressing.
There are only three predicates, the first two claimed by Science+Compliance as facts, upon which the claim that CYDY has always known real-time CD12 results:
1) A file named eTMF exists and that file includes the medical records of CD12 patients.
2) Someone at CYDY can open that file and review the medical records.
3) Pourhassan elected to review the eTMF file and the CD12 results it provides.
Can anyone comment on whether these predicates are possible? Is there really such thing as an eTMF file? Does it include all of the CD12 patient medical records, including blood test results?
Finally, and most importantly, who at CYDY is allowed to access the eTMF and are they allowed to publicly reveal what they learned from the eTMF?
A serious deficit in Science+Compliance's analysis is that he does not understand leronlimab and CCR5.
CCR5 receptor occupancy, which is performed on all CD12 patients, distinguishes between leronlimab and placebo arms with 100% accuracy. Science+Compliance discusses RANTES, bilirubin and others in the context of whether or not the medical records can indicate LL or placebo, but none of those are relevant. CCR5 receptor occupancy is 100% dispositiv of who got LL and who is on placebo.
So if there exists an electronic file that contains medical records for all CD12 patients, and if that file is accessible to CYDY employees, then anyone at CYDY interested to look can see the CD12 progress in real time.
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