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Posted On: 04/05/2021 7:49:02 PM
Post# of 148878
Hopefully, they are talking to Samsung about spending some of that new money on another batch of Leronlimab!
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 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!
That's my guess for the CC delay and also MHRA negotiations and approval.
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 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!
That's my guess for the CC delay and also MHRA negotiations and approval.
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