Back on July 6th I posted -
"But when she got there, the cupboard was bare."
In the interview with Dr. Been, Pourhassan dodged the question of supply of Leronlimab. Dr. Been correctly observed that Cytodyn was going to need billions and billions of doses in the near future for all the indications it can treat. Each treatment for whatever is going to take multiple doses.
I maintain that there is probably no possibility of approval for Leronlimab for much of anything until there is something in the cupboard, literally. There is no rush to end the trials early no matter how well things are going until more product is in hand.
This is not Pourhassen's fault. Where is all the Operation Warp Speed help, the CTAP help, the BARTA help? I do so hope Pourhassen knows more that what he is saying but I don't know why he would not tell us about expidited supply provisions. Would it indicate that approval of Leronlimab is all but a done deal? Massive supply is on the way? But Pourhassen only, again, mentioned the 1.2 million shares due BY THE END OF THE YEAR! 300,000 treatments worth!
There's a huge disconnect here. What's the answer?
I now believe the disconnect between Cytodyn and the OWS "partnership" of government bureaus to expedite a way to fight the virus was Cytodyn's doing. Cytodyn of course knew about OWS, CTAP, BARDA and half a dozen other government programs to aid drug development but they didn't apply for help and wanted to do things their way. And the government said, "OK."
I don't know why Cytodyn chose to go this route. The government didn't care because they probably didn't think Leronlimab would amount to anything, especially compared to what BP could come up with. Perhaps Cytodyn didn't like the terms they saw that came with government cooperation. Or perhaps they were afraid cooperation would endanger the development of Leronlimab for all the other indications it could possibly apply to.
Perhaps Cytodyn, knowing what they had in Leronlimab, wanted the government to come begging for Leronlimab so they could control the term of any cooperation agreement. I don't know!
I do believe that the letter Cytodyn and Patterson got from OWS was just an invitation to participate in OWS, at this late date! Patterson said something about how Cytodyn "may" do something in response to the letter, if I remember correctly.
I have called NIH and the CDC and NIAID and more and none of them have Cytodyn and Leronlimab on their radar because Cytodyn has dealt only with the FDA. Leronlimab does has a large presence at NIH but only in their "AIDSinfo" section.
https://aidsinfo.nih.gov/drugs/423/leronlimab/0/patient
But there is no spillover into anything Covid related. Seems stupid but its the truth! Go to -
https://www.niaid.nih.gov/search/niaidsite?search=leronlimab
There are 2 other databases on that page where you can do a search for Leronlimab. Same results, ZIP!
The most troubling implication of this to me is that nothing is being done about providing supply of Leronlimab. Our cupboard is still, essentially, bare. We don't even know if we have gotten anything from Samsung yet or what the delivery dates are.
This can't help the case for Leronlimab's approval! Again I agree with what I heard from Lalizari - supply will be our biggest problem going forward. It is neither timely or large enough!
"But when she got there, the cupboard was bare."
In the interview with Dr. Been, Pourhassan dodged the question of supply of Leronlimab. Dr. Been correctly observed that Cytodyn was going to need billions and billions of doses in the near future for all the indications it can treat. Each treatment for whatever is going to take multiple doses.
I maintain that there is probably no possibility of approval for Leronlimab for much of anything until there is something in the cupboard, literally. There is no rush to end the trials early no matter how well things are going until more product is in hand.
This is not Pourhassen's fault. Where is all the Operation Warp Speed help, the CTAP help, the BARTA help? I do so hope Pourhassen knows more that what he is saying but I don't know why he would not tell us about expidited supply provisions. Would it indicate that approval of Leronlimab is all but a done deal? Massive supply is on the way? But Pourhassen only, again, mentioned the 1.2 million shares due BY THE END OF THE YEAR! 300,000 treatments worth!
There's a huge disconnect here. What's the answer?
I now believe the disconnect between Cytodyn and the OWS "partnership" of government bureaus to expedite a way to fight the virus was Cytodyn's doing. Cytodyn of course knew about OWS, CTAP, BARDA and half a dozen other government programs to aid drug development but they didn't apply for help and wanted to do things their way. And the government said, "OK."
I don't know why Cytodyn chose to go this route. The government didn't care because they probably didn't think Leronlimab would amount to anything, especially compared to what BP could come up with. Perhaps Cytodyn didn't like the terms they saw that came with government cooperation. Or perhaps they were afraid cooperation would endanger the development of Leronlimab for all the other indications it could possibly apply to.
Perhaps Cytodyn, knowing what they had in Leronlimab, wanted the government to come begging for Leronlimab so they could control the term of any cooperation agreement. I don't know!
I do believe that the letter Cytodyn and Patterson got from OWS was just an invitation to participate in OWS, at this late date! Patterson said something about how Cytodyn "may" do something in response to the letter, if I remember correctly.
I have called NIH and the CDC and NIAID and more and none of them have Cytodyn and Leronlimab on their radar because Cytodyn has dealt only with the FDA. Leronlimab does has a large presence at NIH but only in their "AIDSinfo" section.
https://aidsinfo.nih.gov/drugs/423/leronlimab/0/patient
But there is no spillover into anything Covid related. Seems stupid but its the truth! Go to -
https://www.niaid.nih.gov/search/niaidsite?search=leronlimab
There are 2 other databases on that page where you can do a search for Leronlimab. Same results, ZIP!
The most troubling implication of this to me is that nothing is being done about providing supply of Leronlimab. Our cupboard is still, essentially, bare. We don't even know if we have gotten anything from Samsung yet or what the delivery dates are.
This can't help the case for Leronlimab's approval! Again I agree with what I heard from Lalizari - supply will be our biggest problem going forward. It is neither timely or large enough!
1
