mels, excellent questions. I don't think anyone knows the answers.
I thought MDV's RO comments were about covid and not HIV but what do I know.
As for what is going on with Cytodyn and HIV RO testing to support the BLA, I am just as confused as anyone else.
From what I can tell, Cytodyn has never made any coherent, intelligible statement as to why RO testing is a part of the HIV BLA process.
Well, I guess with maybe one exception.
During the last conference call, Dr. Chris Recknor did say the FDA was interested in HIV BLA receptor occupancy testing to set the dose of leronlimab in HIV.
I don't think Recknor was supposed to say that out loud.
It was Recknor's first time on a conference call.
If the FDA was interested in RO for purpose of dosing, Cytodyn could have said that before but I don't think Cytodyn ever did.
I think the reason that Recknor was supposed to keep quiet on that particular subject is because if Cytodyn needs an RO test for the HIV BLA to succeed, then Cytodyn could have a very serious problem with the HIV BLA.
Now of course there is absolutely no reason whatsoever that the FDA should be interested in RO testing as part of the HIV BLA.
There was no RO testing in the HIV clinical trials. Just give the person the medicine and see if the problem gets taken care of.
So it seems inconceivable that Cytodyn could conduct a trial, show the medicine works, and after the trial is completely don and over with, the FDA says "Well, this data is great, and your medicine seems to work great, but we really prefer a trial protocol different than testing the medicine on people to see if it works."
If the FDA really wants RO testing for the HIV BLA, Cytodyn could be in for a long delay.
During the last conference call, I thought I heard the following comments regarding RO test development for HIV BLA:
1) Cytodyn had two companies working on developing RO testing but both failed
2) Kelly and Recknor have a new idea for RO testing which they are working on
3) RO testing is ongoing for HIV trial patients who have continued in the extension phase of the HIV trials.
These different statements contradict each other. How could RO testing be ongoing if 1) the tests are in development, 2) the tests failed, or 3) Kelly and Recknor have a new one?
But hey, I am just totally confused so no surprise I can't figure out what they said in the last conference call.
My suspicion is that the HIV BLA doesn't matter, at least not financially.
Because there is not going to be any leronlimab left for HIV patients anyway.
My suspicion is that an exponential uptake of leronllimab for covid is about to begin.
Maybe there is even a math model in the covid uptake rate posted on this board.
Three weeks ago we had one and only one patient in the phillippines.
Two weeks ago we had 28 patients dosed in the phillippines.
Yesterday the inadvertent reveal of Randy Nicolas private comment says 250 patients this week.
If this rate of exponential uptake continues, next week will see 2500 patient requests in the Phillippines.
And the week after that, 25,000 patient requests in the Phillippines. At which point the Phillippines has pretty much used up all their 200,000 vials.
I thought MDV's RO comments were about covid and not HIV but what do I know.
As for what is going on with Cytodyn and HIV RO testing to support the BLA, I am just as confused as anyone else.
From what I can tell, Cytodyn has never made any coherent, intelligible statement as to why RO testing is a part of the HIV BLA process.
Well, I guess with maybe one exception.
During the last conference call, Dr. Chris Recknor did say the FDA was interested in HIV BLA receptor occupancy testing to set the dose of leronlimab in HIV.
I don't think Recknor was supposed to say that out loud.
It was Recknor's first time on a conference call.
If the FDA was interested in RO for purpose of dosing, Cytodyn could have said that before but I don't think Cytodyn ever did.
I think the reason that Recknor was supposed to keep quiet on that particular subject is because if Cytodyn needs an RO test for the HIV BLA to succeed, then Cytodyn could have a very serious problem with the HIV BLA.
Now of course there is absolutely no reason whatsoever that the FDA should be interested in RO testing as part of the HIV BLA.
There was no RO testing in the HIV clinical trials. Just give the person the medicine and see if the problem gets taken care of.
So it seems inconceivable that Cytodyn could conduct a trial, show the medicine works, and after the trial is completely don and over with, the FDA says "Well, this data is great, and your medicine seems to work great, but we really prefer a trial protocol different than testing the medicine on people to see if it works."
If the FDA really wants RO testing for the HIV BLA, Cytodyn could be in for a long delay.
During the last conference call, I thought I heard the following comments regarding RO test development for HIV BLA:
1) Cytodyn had two companies working on developing RO testing but both failed
2) Kelly and Recknor have a new idea for RO testing which they are working on
3) RO testing is ongoing for HIV trial patients who have continued in the extension phase of the HIV trials.
These different statements contradict each other. How could RO testing be ongoing if 1) the tests are in development, 2) the tests failed, or 3) Kelly and Recknor have a new one?
But hey, I am just totally confused so no surprise I can't figure out what they said in the last conference call.
My suspicion is that the HIV BLA doesn't matter, at least not financially.
Because there is not going to be any leronlimab left for HIV patients anyway.
My suspicion is that an exponential uptake of leronllimab for covid is about to begin.
Maybe there is even a math model in the covid uptake rate posted on this board.
Three weeks ago we had one and only one patient in the phillippines.
Two weeks ago we had 28 patients dosed in the phillippines.
Yesterday the inadvertent reveal of Randy Nicolas private comment says 250 patients this week.
If this rate of exponential uptake continues, next week will see 2500 patient requests in the Phillippines.
And the week after that, 25,000 patient requests in the Phillippines. At which point the Phillippines has pretty much used up all their 200,000 vials.
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