Monday, September 18, 2017 2:28:00 PM
In reality - there is a positive confirmation as follows
- in 90% of case FDA will give YES or No decision within 60 days from date of application
- in case no decision is done, then FDA has give a feedback to company within 100 days with no exception on where the application stands.
If we do not get update this week, it will mean that there are some more detailed review happening and we could see approval or query which will need to be responded within 180 days.
So A non-decision in 60 days could indicate some complexity in giving approval.
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