At 1:05:00 of the September 8 Cytodyn conference call, Pourhassan says that the HIV BLA delay will be controlled by the schedule upon which a new CRO can complete "the certain assays that the fda has asked us to do."
Usually, its very difficult to decode meaning of Pourhassan's public comments.
But this particular comment has som much specific detail that it's hard to offer an alternative scenario as to why the HIV BLA will not be fully submitted on Oct 15.
The need for a new contract with a new CRO so the new CRO can conduct a "certain assay that the fda has asked us to do" seems sufficiently specific that it is likely factual.
So a new CRO is needed to do a new assay that the FDA has asked for.
An assay is a chemistry experiment.
Apparently the old CRO, perhaps Amarex, cannot conduct the chemistry experiment requested by the FDA.
Someone at the FDA has requested an oddball chemistry experiment that is not easy to do.
I would say that every chemistry experiment ever conducted on every HIV blood sample ever possessed by Cytody was an "easy" experiment.
For certain the experiments were all sufficiently "easy" that Amarex could do them.
Of course, Cytodyn could be in the middle of a falling out with Amarex and Amarex has simply chosen not to do the FDA arequested experiment, but I don't think that's what is happening here.
I will go out on a limb and say that the assay requested by the FDA will not be conducted on the blood of any patient in the HIV combo or mono trials.
Recknor's July 4 initial reading of the FDA response to Recknor's RO submission was very positive. Recknor certainly didn't mention anything about additional chemistry experiments.
Recknor has always been very forthright in his commentary. Probably Recknor knew of the FDA's request for an additional assay when he made his very positive comments on around July 4. My take is that while the new chemistry test is requested, this new chemistry test is not a primary part of the package. I suspect that the new chemistry test is intended, by the FDA person who suggested it, as something that can put a finer point on RO testing for dose justification.
The full Q&A, at 1:05:00, is here:
Question: For me I consider the hiv bla to be the most important discussion topic for today’s conference call. What is the exact status of the HIV BLA, to include the status of the various modules that compose the bla, and do you expect to meet the october 15 deadline, if not then when?
Pourhassan: So when a person doesn’t answer the question straight head on, that means the answer is probably no, but lets leave it at that. October 15 is for bla submission. But October 15 also could be the date that we read the results of covid19 to get emergency use authorization. if we do get that do we have enough vials? No. 1.2 million, seven hundred some thousand is already dedicated to a contract that we signed in Brazil and we wont have any. so the most important thing for us is to make sure our manufacturing is ready to make enough vials. The success is coming and its coming in a big way, in my opinion. Now bla if we are delayed one month, two months, we will give you the exact timeline, but we have to get the contract signed to do the certain assays that the fda has asked us to do. And if those are 100% coming to be October 15, we’ll announce that. But if its December 15, we’l announce that. but you guys have to be patient. There are 30 indications, remember that. The onve that’s very close to getting approval is not HIV. It’s called covid19. This is two months or three months from today. We could have interim analysis readout. That’s powerful.
Usually, its very difficult to decode meaning of Pourhassan's public comments.
But this particular comment has som much specific detail that it's hard to offer an alternative scenario as to why the HIV BLA will not be fully submitted on Oct 15.
The need for a new contract with a new CRO so the new CRO can conduct a "certain assay that the fda has asked us to do" seems sufficiently specific that it is likely factual.
So a new CRO is needed to do a new assay that the FDA has asked for.
An assay is a chemistry experiment.
Apparently the old CRO, perhaps Amarex, cannot conduct the chemistry experiment requested by the FDA.
Someone at the FDA has requested an oddball chemistry experiment that is not easy to do.
I would say that every chemistry experiment ever conducted on every HIV blood sample ever possessed by Cytody was an "easy" experiment.
For certain the experiments were all sufficiently "easy" that Amarex could do them.
Of course, Cytodyn could be in the middle of a falling out with Amarex and Amarex has simply chosen not to do the FDA arequested experiment, but I don't think that's what is happening here.
I will go out on a limb and say that the assay requested by the FDA will not be conducted on the blood of any patient in the HIV combo or mono trials.
Recknor's July 4 initial reading of the FDA response to Recknor's RO submission was very positive. Recknor certainly didn't mention anything about additional chemistry experiments.
Recknor has always been very forthright in his commentary. Probably Recknor knew of the FDA's request for an additional assay when he made his very positive comments on around July 4. My take is that while the new chemistry test is requested, this new chemistry test is not a primary part of the package. I suspect that the new chemistry test is intended, by the FDA person who suggested it, as something that can put a finer point on RO testing for dose justification.
The full Q&A, at 1:05:00, is here:
Question: For me I consider the hiv bla to be the most important discussion topic for today’s conference call. What is the exact status of the HIV BLA, to include the status of the various modules that compose the bla, and do you expect to meet the october 15 deadline, if not then when?
Pourhassan: So when a person doesn’t answer the question straight head on, that means the answer is probably no, but lets leave it at that. October 15 is for bla submission. But October 15 also could be the date that we read the results of covid19 to get emergency use authorization. if we do get that do we have enough vials? No. 1.2 million, seven hundred some thousand is already dedicated to a contract that we signed in Brazil and we wont have any. so the most important thing for us is to make sure our manufacturing is ready to make enough vials. The success is coming and its coming in a big way, in my opinion. Now bla if we are delayed one month, two months, we will give you the exact timeline, but we have to get the contract signed to do the certain assays that the fda has asked us to do. And if those are 100% coming to be October 15, we’ll announce that. But if its December 15, we’l announce that. but you guys have to be patient. There are 30 indications, remember that. The onve that’s very close to getting approval is not HIV. It’s called covid19. This is two months or three months from today. We could have interim analysis readout. That’s powerful.
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