Pourhassan: Patterson is running blood tests on severe/critical trial.
At around 6:56pm pacific time in today's interview with Dr. Been, Pourhassan clearly says that Patterson is running blood tests for both the CD10 and CD12 trials.
I think this is the first and only time the CYDY has unequivocally stated that Patterson is running blood work on both the mild/moderate and severe/critical trial. Blood work is specifically called out as an endpoint in the mild/moderate trial on clinicaltrials.gov. Blood work is nowhere to be found on clinicaltrials.gov for the severe/critical trial.
As many posts on this board have noted, the question of whether or not Patterson is doing blood work on the severe/critical trial is potentially critically important as to whether CYDY is really and truly blinded as to the 28 day all cause mortality primary endpoint in the severe/critical trial.
As many posts on this board have noted, each blood vial that arrives at Patterson's lab is labelled with a unique patient identifier. As far as unblinding is concerned, this unique patient identifier is just as good as the patient's name and social security number.
So with today's presentation, we know that Patterson is getting blood from the severe/critical trial.
I guess it remains unknown as to exactly what data Patterson is collecting in the severe/critical trial as well as the frequency with which that data is collected. It is only certain that Patterson is getting something from the severe/critical trial.
A few days ago, poster Kabonk suggested that collection of bolld samples for submission to Patterson in the severe/critical trial would be managed by the patient consent form used in the clinical trial, and that the patient consent form is directly controlled by the hospital Institutional Review Board at the location of the trial. The IRB/consent form control is predicated upon the fact that Patterson blood work is not specifically called out in the severe/critical trial protocol, unlike the specific call out in the mild/moderate trial.
So bottom line, Patterson has at least some information regarding the 28 day all cause primary endpoint in the severe/critical trial. If Cytodyn has done a good job securing blood samples for Patterson's blood work in the severe/critical trial, then Patterson knows the p-value of the 28 day all cause mortality primary endpoint in the severe/critical trial, and Patterson knows that result in real time on a day-by-day basis.
Shortly after 6:56pm pacific time in today's video, Pourhassan offered that he planned to release both mild/moderate and severe/critical trial data at the same time.
Pourhassan did not explain how he could get the severe/critical trial data released simultaneously as the mild/moderate. Pourhassan doesn't even know when the mild/moderate trial data, which ended July 1, will release because that data must be administrated by the hospitals. Pourhass thought he would get mild/moderate sometime in July, as early as ten days from today but he just doesn't know when that will happen.
So I wonder, how is possible to synchronize the severe/critical data release to the mild/moderate release given Pourhassan doesn't know when the mild/moderate data will release and Pourhassan also doesn't know what interim analysis the FDA will allow on the severe/critical trial.
Well, if Patterson knows the daily p-value for the severe/critical trial, and the FDA knows that Patterson knows, wouldn't that be a way to synchronize the severe/critical interim analysis to the mild/moderate data release? I don't see how else they could synchronize the two datasets.
At around 6:56pm pacific time in today's interview with Dr. Been, Pourhassan clearly says that Patterson is running blood tests for both the CD10 and CD12 trials.
I think this is the first and only time the CYDY has unequivocally stated that Patterson is running blood work on both the mild/moderate and severe/critical trial. Blood work is specifically called out as an endpoint in the mild/moderate trial on clinicaltrials.gov. Blood work is nowhere to be found on clinicaltrials.gov for the severe/critical trial.
As many posts on this board have noted, the question of whether or not Patterson is doing blood work on the severe/critical trial is potentially critically important as to whether CYDY is really and truly blinded as to the 28 day all cause mortality primary endpoint in the severe/critical trial.
As many posts on this board have noted, each blood vial that arrives at Patterson's lab is labelled with a unique patient identifier. As far as unblinding is concerned, this unique patient identifier is just as good as the patient's name and social security number.
So with today's presentation, we know that Patterson is getting blood from the severe/critical trial.
I guess it remains unknown as to exactly what data Patterson is collecting in the severe/critical trial as well as the frequency with which that data is collected. It is only certain that Patterson is getting something from the severe/critical trial.
A few days ago, poster Kabonk suggested that collection of bolld samples for submission to Patterson in the severe/critical trial would be managed by the patient consent form used in the clinical trial, and that the patient consent form is directly controlled by the hospital Institutional Review Board at the location of the trial. The IRB/consent form control is predicated upon the fact that Patterson blood work is not specifically called out in the severe/critical trial protocol, unlike the specific call out in the mild/moderate trial.
So bottom line, Patterson has at least some information regarding the 28 day all cause primary endpoint in the severe/critical trial. If Cytodyn has done a good job securing blood samples for Patterson's blood work in the severe/critical trial, then Patterson knows the p-value of the 28 day all cause mortality primary endpoint in the severe/critical trial, and Patterson knows that result in real time on a day-by-day basis.
Shortly after 6:56pm pacific time in today's video, Pourhassan offered that he planned to release both mild/moderate and severe/critical trial data at the same time.
Pourhassan did not explain how he could get the severe/critical trial data released simultaneously as the mild/moderate. Pourhassan doesn't even know when the mild/moderate trial data, which ended July 1, will release because that data must be administrated by the hospitals. Pourhass thought he would get mild/moderate sometime in July, as early as ten days from today but he just doesn't know when that will happen.
So I wonder, how is possible to synchronize the severe/critical data release to the mild/moderate release given Pourhassan doesn't know when the mild/moderate data will release and Pourhassan also doesn't know what interim analysis the FDA will allow on the severe/critical trial.
Well, if Patterson knows the daily p-value for the severe/critical trial, and the FDA knows that Patterson knows, wouldn't that be a way to synchronize the severe/critical interim analysis to the mild/moderate data release? I don't see how else they could synchronize the two datasets.
1
