The FDA never believe the hype . It's a refined process.
First 45 days Vetting ,
next was processing but no data , none , can't process the application without supportive data , pretty simple...
Great that the FDA have said they will keep open the application ,, I would say we have 10 to 15 working days to supply the Phase I/ II MND Data and then a complete resubmission will be required,, because its a stack that is being worked through from Companies that have supplied the supportive information and the FDA will not penalise them by taking up time to process an application that is incomplete and void of Data... NZT
The question is 'Why has the Phase I/II data taken so long to analyse" ?
Ann: FDA Provides Clear Feedback for ODD Approval, page-8
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