The FDA has actually tried to speed up combo appro
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Posted On: 07/15/2020 11:37:36 AM
The FDA has actually tried to speed up combo approval by allowing data from the mono trial to be used.
What happened is last year Cytodyn let the FDA know the effectiveness of 700 mg so the FDA said to go with that. And instead of forcing a new trial, they allowed the seemingly unprecedented workaround of using the mono trial data.
As Nader said at the 37:45 min mark of the PC:
"They wanted to have the 700 mg that we said is better than 350.... The FDA did something spectacular for us, they didn't make us do the trial over. The FDA had to go have a meeting and they voted on that and they came back and said congratulations we will allow this for one time".
Now the delay is just giving them the full mono data. Maybe Cytodyn jumped the gun a little with the BLA submission, maybe there was some confusion with the full scope of the mono trial data needed. I really doubt that it has anything to do with covid and is actually a result of the FDA giving Cytodyn a break.
What happened is last year Cytodyn let the FDA know the effectiveness of 700 mg so the FDA said to go with that. And instead of forcing a new trial, they allowed the seemingly unprecedented workaround of using the mono trial data.
As Nader said at the 37:45 min mark of the PC:
"They wanted to have the 700 mg that we said is better than 350.... The FDA did something spectacular for us, they didn't make us do the trial over. The FDA had to go have a meeting and they voted on that and they came back and said congratulations we will allow this for one time".
Now the delay is just giving them the full mono data. Maybe Cytodyn jumped the gun a little with the BLA submission, maybe there was some confusion with the full scope of the mono trial data needed. I really doubt that it has anything to do with covid and is actually a result of the FDA giving Cytodyn a break.
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