I said in msg 85375 - "Since my joining this b
Post# of 155006
(Total Views: 614)
Posted On: 04/15/2021 12:52:50 PM
I said in msg 85375 -
"Since my joining this board I have been saying that the FDA would not be in a hurry to give approval to Cytodyn if they can't demonstrate a proven ability to deliver the drug. That is one of the reasons they like working with BP. CDER is very big on all supply issues.
Perhaps supply concerns were behind the FDA's desire to limit the dosage in the CD12 trials to 2 doses! Now with 4 doses looking like the future dosage protocol and the LH trials and foreign buyers, we're going to need a lot more Leronlimab, so much more!"
Because Cytodyn is small, pre-revenue and does not have a PROVEN ABILITY TO DELIVER large quantities of Leronlimab, the FDA is reluctant to give Cytodyn any kind of approval, EUA or otherwise except eIND.
They, no doubt, would like for Cytodyn to work with them ON THEIR TERMS or sell out to BP or they hope some BP outfit will come up with another drug that can do what Leronlimab does. Any of these things would deal with the supply problem and that's what they want!
Cytodyn's conumdrum is they have to make sales somehow large enough to buy more Leronlimab!
So with the pitiful amount of Leronlimab Cytodyn has on hand, especially if it is going to take more doses to treat critical patients, EVERY TIME we hear what sounds like GOOD NEWS like 200K to the Philippines or 500K to Brazil or use of Leronlimab for another indication or more doses per treatment, anything, the FDA probably looks COLDLY on Cytodyn!
If Cytodyn could supply the needed quantities to treat 100 million people like BP can do with the vaccines, the FDA would approve them immediately! If they can't, they get the treatment they are getting now and not because of corruption.
Cytodyn has chosen the door-to-door salesman route - knock on a lot of doors until someone buys. This strategy will probably work. But in the mean time, Leronlimab is getting little chance to save lives!
"Since my joining this board I have been saying that the FDA would not be in a hurry to give approval to Cytodyn if they can't demonstrate a proven ability to deliver the drug. That is one of the reasons they like working with BP. CDER is very big on all supply issues.
Perhaps supply concerns were behind the FDA's desire to limit the dosage in the CD12 trials to 2 doses! Now with 4 doses looking like the future dosage protocol and the LH trials and foreign buyers, we're going to need a lot more Leronlimab, so much more!"
Because Cytodyn is small, pre-revenue and does not have a PROVEN ABILITY TO DELIVER large quantities of Leronlimab, the FDA is reluctant to give Cytodyn any kind of approval, EUA or otherwise except eIND.
They, no doubt, would like for Cytodyn to work with them ON THEIR TERMS or sell out to BP or they hope some BP outfit will come up with another drug that can do what Leronlimab does. Any of these things would deal with the supply problem and that's what they want!
Cytodyn's conumdrum is they have to make sales somehow large enough to buy more Leronlimab!
So with the pitiful amount of Leronlimab Cytodyn has on hand, especially if it is going to take more doses to treat critical patients, EVERY TIME we hear what sounds like GOOD NEWS like 200K to the Philippines or 500K to Brazil or use of Leronlimab for another indication or more doses per treatment, anything, the FDA probably looks COLDLY on Cytodyn!
If Cytodyn could supply the needed quantities to treat 100 million people like BP can do with the vaccines, the FDA would approve them immediately! If they can't, they get the treatment they are getting now and not because of corruption.
Cytodyn has chosen the door-to-door salesman route - knock on a lot of doors until someone buys. This strategy will probably work. But in the mean time, Leronlimab is getting little chance to save lives!
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