CYDY takes a shot at the FDA: UK HIV pre-meeting is 350mg!!!
Well, well, some regulatory tactical wafare from Pourhassan. Very interesting.
CYDY is seeking a pre-approval meeting the the UK authorities for HIV combo therapy.
But there is a potentially significant twist.
CYDY will ask for approval for the 350 milligram dose in HIV combo therapy.
In the US, Cytodyn's HIV combo therapy BLA has been delayed because the FDA suggested that 700 milligrams might work better.
While this suggestion is generally favorable to Cytodyn as the FDA requested only safety studies on the 700 milligram dose and not re-doing the entire trial.
But now Pourhassan's patience appears to have been strained by the FDA's recent ask for more data on HIV combo when Cytodyn wanted a PDUFA data.
So Pourhassan's solution is to file for approval in the UK using the 350 milligram dose. All of the i's and t's have been dotted and crossed at 350 milligrams for well over a year.
Maybe UK will be receptive to the 350 mg dose and provide a quick approval?
Well, well, some regulatory tactical wafare from Pourhassan. Very interesting.
CYDY is seeking a pre-approval meeting the the UK authorities for HIV combo therapy.
But there is a potentially significant twist.
CYDY will ask for approval for the 350 milligram dose in HIV combo therapy.
In the US, Cytodyn's HIV combo therapy BLA has been delayed because the FDA suggested that 700 milligrams might work better.
While this suggestion is generally favorable to Cytodyn as the FDA requested only safety studies on the 700 milligram dose and not re-doing the entire trial.
But now Pourhassan's patience appears to have been strained by the FDA's recent ask for more data on HIV combo when Cytodyn wanted a PDUFA data.
So Pourhassan's solution is to file for approval in the UK using the 350 milligram dose. All of the i's and t's have been dotted and crossed at 350 milligrams for well over a year.
Maybe UK will be receptive to the 350 mg dose and provide a quick approval?
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