“IMO the worst case scenario is that the FDA ask
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Posted On: 01/13/2020 10:45:25 AM
“IMO the worst case scenario is that the FDA ask for more data before making a decision (not disapproval, but delay to get more data points)”
Is there a history of the FDA delaying a BTD response to request more data? And can CYDY submit data from the 2 additional patients to the FDA to support the already filed BTD packet?
These are important questions.
Is there a history of the FDA delaying a BTD response to request more data? And can CYDY submit data from the 2 additional patients to the FDA to support the already filed BTD packet?
These are important questions.
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