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Posted On: 03/24/2021 3:32:59 PM
Post# of 155802
Thanks much, z. That's a very interesting theory.
Part of the CYDY HIV narrative has always been that the FDA did Cytodyn a "favor" by suggesting that HIV combo therapy might be approved at 700mg despite the fact that the combo trial was conducted at 525mg.
Part of this narrative is that the FDA said "OK, just show us some safety data at 700mg and maybe we will approve your combo therapy at 700mg even though the trial was at 350 and 535."
So if you are correct, through the execution of this "favor" over the last two years the fact developed that RO testing may discriminate HIV non-responders and thus RO testing may be essential tool in any commercial roll-out of the product. Perhaps the FDA observes the essential nature of RO testing and deems RO testing essential for FDA approval.
There are perhaps some arguments as to why this theory might not be correct:
1) Whose blood will be tested? What good is a test if there is no blood to test?
2) If RO testing of HIV patients didn't work, how does the FDA develop the conclusion that the RO testing is an essential part of the leronlimab HIV program? And if RO testing did work, why does the FDA need more tests?
3) HIV non-responders were screeneed out of the HIV combo therapy trial at week 12 or thereabouts. If the HIV patient doesn't respond to leronlimab, then they just drop them from the trial. Thats the design of the HIV combo trial. In the spreadsheets that Cytodyn has produced, every patient is a responder. In all those spreadsheets, there are maybe one hundred patients? None of those patients are trial failures for non-response. There are some spikes in the viral loads, but the spikes always recovered. Maybe Cytodyn has other trial patients who performed more poorly and the FDA has seen that data?
Regardless of any theory of RO testing working or not-working, developed or in development, there are very simple straightforward questions that Cytodyn is unable or unwilling to answer:
1) Whose blood will be RO tested in the future in support of the HIV BLA?
2) Why is RO testing dispositive of ANYTHING in HIV?
3) Why is the FDA pursuing RO testing in the HIV BLA?
These are simple, obvious questions.
Instead of directly addressing any of these questions, CYDY says "We'll file the HIV BLA in June and then we'll add RO testing in July" or some other such similar. How does that even make any sense?
It seems to me that RO testing is involved in the HIV BLA, Since RO testing is part of the HIV BLA, then any unfavorable disposition of RO testing will prevent BLA approval.
Investors are completely in the dark about this. CYDY says "We'll resolve it in July".
I can't find any reason why Cytodyn's RO testing situation is any different today than it was six months ago. What's different today?
Part of the CYDY HIV narrative has always been that the FDA did Cytodyn a "favor" by suggesting that HIV combo therapy might be approved at 700mg despite the fact that the combo trial was conducted at 525mg.
Part of this narrative is that the FDA said "OK, just show us some safety data at 700mg and maybe we will approve your combo therapy at 700mg even though the trial was at 350 and 535."
So if you are correct, through the execution of this "favor" over the last two years the fact developed that RO testing may discriminate HIV non-responders and thus RO testing may be essential tool in any commercial roll-out of the product. Perhaps the FDA observes the essential nature of RO testing and deems RO testing essential for FDA approval.
There are perhaps some arguments as to why this theory might not be correct:
1) Whose blood will be tested? What good is a test if there is no blood to test?
2) If RO testing of HIV patients didn't work, how does the FDA develop the conclusion that the RO testing is an essential part of the leronlimab HIV program? And if RO testing did work, why does the FDA need more tests?
3) HIV non-responders were screeneed out of the HIV combo therapy trial at week 12 or thereabouts. If the HIV patient doesn't respond to leronlimab, then they just drop them from the trial. Thats the design of the HIV combo trial. In the spreadsheets that Cytodyn has produced, every patient is a responder. In all those spreadsheets, there are maybe one hundred patients? None of those patients are trial failures for non-response. There are some spikes in the viral loads, but the spikes always recovered. Maybe Cytodyn has other trial patients who performed more poorly and the FDA has seen that data?
Regardless of any theory of RO testing working or not-working, developed or in development, there are very simple straightforward questions that Cytodyn is unable or unwilling to answer:
1) Whose blood will be RO tested in the future in support of the HIV BLA?
2) Why is RO testing dispositive of ANYTHING in HIV?
3) Why is the FDA pursuing RO testing in the HIV BLA?
These are simple, obvious questions.
Instead of directly addressing any of these questions, CYDY says "We'll file the HIV BLA in June and then we'll add RO testing in July" or some other such similar. How does that even make any sense?
It seems to me that RO testing is involved in the HIV BLA, Since RO testing is part of the HIV BLA, then any unfavorable disposition of RO testing will prevent BLA approval.
Investors are completely in the dark about this. CYDY says "We'll resolve it in July".
I can't find any reason why Cytodyn's RO testing situation is any different today than it was six months ago. What's different today?
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