Actually FDA has internal guidelines on target and lead times for various submissions. They publish reports showing how many they met and how many they missed.
They give additional consulting meetings, they publish their advisory committee meetings in advance for the year. Have you looked at them?
What kind of update M has given? And he has one drug to follow. FDA has literally hundreds of companies and thousand of drugs and all the crooked companies trying to find loopholes. They have to ensure safety of patient first.
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