Very good points thriftycents. Hard to argue with
Post# of 148174
I would only say that I bet CytoDyn does indeed have a good feeling for what the FDA is doing with this meeting, and that the duration of the Multidisciplinary Review is no less than 30 days -- not up to 30 days.
The FDA granted a Rolling Review back in Q1-2019, did they really have to wait until the 60th day to issue a RTF?
Did they really have to demand the massive undertaking of rushing the Integrated Assessment of the Mono CD03 even though they only needed 700mg safety data?
And now they are "making us an offer we can't refuse" (The Godfather) for an Multidisciplinary Review that is supposedly necessary due to a dosage change THAT WE SELECTED (Bullsht), and that will last no less than 30 days -- after which (as the letter states) we will need additional time to process their feedback, make the necessay changes, and resubmit the BLA.
It also seems clear to me that they have not accepted CytoDyn's request to append the Mono indication onto the Combo BLA.
I think everyone is entitled to their own interpretation of these data points.