(Total Views: 668)
Posted On: 09/07/2020 12:27:34 PM
Post# of 154928
Taking a step back from the conspiracy theories ...
If we were to apply Occam's Razor to this equation, we might conclude that the Type A Meeting questions that CytoDyn presented were complicated enough to cause the FDA to realize that a verbal call (not WRO) was going to be necessary.
Furthermore, the questions CytoDyn presented might have caused the FDA to realize that they needed to offer CytoDyn the option of a Multidisciplinary Review as a hand-holding solution to prevent more issues with the revised BLA filing.
I accept that the above is possible, and that the 30+ day penalty for the Multidisciplinary Review is simply the cost of having the FDA "bless" the submission before it is re-filed -- and not a sinister move on the part of the FDA.
If we were to apply Occam's Razor to this equation, we might conclude that the Type A Meeting questions that CytoDyn presented were complicated enough to cause the FDA to realize that a verbal call (not WRO) was going to be necessary.
Furthermore, the questions CytoDyn presented might have caused the FDA to realize that they needed to offer CytoDyn the option of a Multidisciplinary Review as a hand-holding solution to prevent more issues with the revised BLA filing.
I accept that the above is possible, and that the 30+ day penalty for the Multidisciplinary Review is simply the cost of having the FDA "bless" the submission before it is re-filed -- and not a sinister move on the part of the FDA.
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