crainsnewyork article is is unusual in many ways, including that it continues CYDY's habit of totally unintelligible communications.
This article is behind a paywall so I can't access it but lorbas has provided at least part of the article.
1) Suddenly Pourhassan is reporting costs for CYDY human clinical trials. Why? Perhaps no reason at all.
2) Seethamraju and Pourhassan seem to collaborate with this interviewer. Perhaps they have always been collaborating more closely than has been reported.
3) "Next week when enrollment hits 75% the FDA could review" or whatever the statement was. Is this statement obviously seriously wrong and simply the result of the author's confusion? lorbas didn't paste that snippet from the article.
"Next week when enrollment hits 75% the FDA could review" is the latest unintelligible communication from Cytodyn.
I would say there are three important corrupted, unintelligible communications from Cytodyn in the last couple weeks:
1) crainsnewyork "Next week when enrollment hits 75% the FDA could review", attributed to Dr. Seethamraju.
2) Pourhassan on Nov 5 cc just past "FDA firewall biostatistician" is in possession of the CD12 data.
3) Seethamraju on Oct 15: "The FDA has CD12 interim results in its possession", which was then totally contradicted by Pourhassan a few days later in the Oct 20 CD12 conference call.
All three of these corrupted, unintelligible communications are related to the same topic: Does the FDA have information on the results of the CD12 interim analysis?
Seems to me that the least corrupted, most intelligible statement in that regard is Pourhassan's comments in the just past Nov 5 conference call.
At one point, around 45:00, Pourhassan clearly, unequivocally states that the "FDA firewall biostatistician" is in possession of CD12 results.
Who knows who or what a "FDA firewall statistician" might be, but apparently Pourhassan believes that this individual has CD12 results in their possession.
At around 48:00 in the call, Pourhassan provides more detail. Pourhassan asserts very strongly that one and only one person, the DSMC statistician, has seen the unblinded data. He then goes on to say that both the DSMC and the "FDA firewall biostastician" have seen the CD12 data.
Perhaps all of this fits together in the following scenario:
1) The only person to observe unblinded data, like names of patients and their outcomes, is the statistician working on behalf of the DSMC.
2) Bewteen Oct 15 and Oct 20, the unblinded DSMC statistician provides a summary report to the DSMC. Obviously, the DSMC gets some summary data or else the DSMC could not make an recommendations whatsoever.
3) At the same time, the same summary report provided to the DSMC was also provided to the "FDA firewall biostatistician", whoever and wherever they may be.
Supposing further that on Oct 15 Dr. Seethamraju knows the identity of the "FDA firewall biostatistician, and the Dr. Seethamraju also knows that the "FDA firewall boistatistician" was provided with the summary CD12 results, then Dr. Seethamraju is justified in making his comments on Oct 15 that "The FDA has the results of the CD12 interiam analysis."
But then during the Oct 20 CD12 conference call, Pourhassan insists that the CD12 interim results were not provided to the FDA, and goes further to emphasize that everyone is blinded except for the one statistician at Amarex. Perhaps on Oct 20 Pourhassan is claiming "no CD12 results to the FDA" on a logical technicality/ Perhaps Pourhassan's logical technicality is that the "FDA firewall biostatistician" is somehow not fully engaged with the rest of the FDA.
So that just leaves the crainsnewyork comment, attributed to Seethamraju, that FDA evaluation could begin next week with the enrollment of the 75th percentile patient.
Probably the crainsnewyork author was just confused by too much information and conflated the FDA participation in the 75% interim analysis with the enrollment of the 75th percentile patient.
Seethamraju's comments are always very aggressive as to timeframes. Maybe he is just pushing to get LL approved. Surely he has more patients and all he wants is to be able to treat them. Right now he has to put 1/3 of his patients on placebo. If he has some placebo patients dying he could be pissed.
I wonder if Seethamraju is blinded as to his patients' blood test results.
When Seethamraju has a CD12 patient, they get the injection but Seethamraju and the other Montefiore medical professionals are not told if the injection was LL or placebo.
However, at day 3, a blood draw is done for CCR5 receptor occupancy testing. Lab results are probably complete a few days later.
Are CCR5 receptor occupancy tests delivered to Dr. Seethamraju and the rest of the medical care team at Montefiore?
If yes, then Seethamraju knows with 100% certainty which of his patients are on LL and which are on placebo. The CCR5 receptor occupancy test is likely near 100% dispositive of whether a patient receied LL or placebo.
If Seethamraju is watching his placebo patients die at a greater rate than his LL patients that has to be a horrific situation for Dr. Seethamraju.
If Seethamraju is watching his patients die because they are not getting LL, then it is certainly understandable that he would be more aggressive with reports and timelines.
Is this the most probable scenario? Seethamraju has the CCR5 occupancy results for his dying patients. He knows Ll pateionts are better off than placebo patients.
Even though Seethamraju is unblinded by lab tests, he may be prohibited from telling anyone else.
The whole scenario is just so weird. CCR5 receptor occupancy blood tests are performed on Dr. Seethamraju's seriously ill and in some cases dying patients.
Its hard for me to believe that the CCR5 receptor occupancy blood tests are witheld from Dr. Seethamraju and the medical care team at Montefiore. But who knows.
This article is behind a paywall so I can't access it but lorbas has provided at least part of the article.
1) Suddenly Pourhassan is reporting costs for CYDY human clinical trials. Why? Perhaps no reason at all.
2) Seethamraju and Pourhassan seem to collaborate with this interviewer. Perhaps they have always been collaborating more closely than has been reported.
3) "Next week when enrollment hits 75% the FDA could review" or whatever the statement was. Is this statement obviously seriously wrong and simply the result of the author's confusion? lorbas didn't paste that snippet from the article.
"Next week when enrollment hits 75% the FDA could review" is the latest unintelligible communication from Cytodyn.
I would say there are three important corrupted, unintelligible communications from Cytodyn in the last couple weeks:
1) crainsnewyork "Next week when enrollment hits 75% the FDA could review", attributed to Dr. Seethamraju.
2) Pourhassan on Nov 5 cc just past "FDA firewall biostatistician" is in possession of the CD12 data.
3) Seethamraju on Oct 15: "The FDA has CD12 interim results in its possession", which was then totally contradicted by Pourhassan a few days later in the Oct 20 CD12 conference call.
All three of these corrupted, unintelligible communications are related to the same topic: Does the FDA have information on the results of the CD12 interim analysis?
Seems to me that the least corrupted, most intelligible statement in that regard is Pourhassan's comments in the just past Nov 5 conference call.
At one point, around 45:00, Pourhassan clearly, unequivocally states that the "FDA firewall biostatistician" is in possession of CD12 results.
Who knows who or what a "FDA firewall statistician" might be, but apparently Pourhassan believes that this individual has CD12 results in their possession.
At around 48:00 in the call, Pourhassan provides more detail. Pourhassan asserts very strongly that one and only one person, the DSMC statistician, has seen the unblinded data. He then goes on to say that both the DSMC and the "FDA firewall biostastician" have seen the CD12 data.
Perhaps all of this fits together in the following scenario:
1) The only person to observe unblinded data, like names of patients and their outcomes, is the statistician working on behalf of the DSMC.
2) Bewteen Oct 15 and Oct 20, the unblinded DSMC statistician provides a summary report to the DSMC. Obviously, the DSMC gets some summary data or else the DSMC could not make an recommendations whatsoever.
3) At the same time, the same summary report provided to the DSMC was also provided to the "FDA firewall biostatistician", whoever and wherever they may be.
Supposing further that on Oct 15 Dr. Seethamraju knows the identity of the "FDA firewall biostatistician, and the Dr. Seethamraju also knows that the "FDA firewall boistatistician" was provided with the summary CD12 results, then Dr. Seethamraju is justified in making his comments on Oct 15 that "The FDA has the results of the CD12 interiam analysis."
But then during the Oct 20 CD12 conference call, Pourhassan insists that the CD12 interim results were not provided to the FDA, and goes further to emphasize that everyone is blinded except for the one statistician at Amarex. Perhaps on Oct 20 Pourhassan is claiming "no CD12 results to the FDA" on a logical technicality/ Perhaps Pourhassan's logical technicality is that the "FDA firewall biostatistician" is somehow not fully engaged with the rest of the FDA.
So that just leaves the crainsnewyork comment, attributed to Seethamraju, that FDA evaluation could begin next week with the enrollment of the 75th percentile patient.
Probably the crainsnewyork author was just confused by too much information and conflated the FDA participation in the 75% interim analysis with the enrollment of the 75th percentile patient.
Seethamraju's comments are always very aggressive as to timeframes. Maybe he is just pushing to get LL approved. Surely he has more patients and all he wants is to be able to treat them. Right now he has to put 1/3 of his patients on placebo. If he has some placebo patients dying he could be pissed.
I wonder if Seethamraju is blinded as to his patients' blood test results.
When Seethamraju has a CD12 patient, they get the injection but Seethamraju and the other Montefiore medical professionals are not told if the injection was LL or placebo.
However, at day 3, a blood draw is done for CCR5 receptor occupancy testing. Lab results are probably complete a few days later.
Are CCR5 receptor occupancy tests delivered to Dr. Seethamraju and the rest of the medical care team at Montefiore?
If yes, then Seethamraju knows with 100% certainty which of his patients are on LL and which are on placebo. The CCR5 receptor occupancy test is likely near 100% dispositive of whether a patient receied LL or placebo.
If Seethamraju is watching his placebo patients die at a greater rate than his LL patients that has to be a horrific situation for Dr. Seethamraju.
If Seethamraju is watching his patients die because they are not getting LL, then it is certainly understandable that he would be more aggressive with reports and timelines.
Is this the most probable scenario? Seethamraju has the CCR5 occupancy results for his dying patients. He knows Ll pateionts are better off than placebo patients.
Even though Seethamraju is unblinded by lab tests, he may be prohibited from telling anyone else.
The whole scenario is just so weird. CCR5 receptor occupancy blood tests are performed on Dr. Seethamraju's seriously ill and in some cases dying patients.
Its hard for me to believe that the CCR5 receptor occupancy blood tests are witheld from Dr. Seethamraju and the medical care team at Montefiore. But who knows.
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