To re-write this for all you over-eager investors:
Day 1. Submit application.
Day 2-7. FDA acknowledges and sends letter of acknowledgement.
Day 8-15. Acceptance review stage, FDA informs applicant that it has been accepted for Substantive Review. This acceptance that should take up to 15 days, took us 116!
Day 16-60. FDA conducts substantive review. THIS IS WHERE WE ARE. We expect the review to be completed BY DAY 60.
Day 61-90. FDA sends final decision... BY DAY 90.
Read it carefully guys. The word "BY" is throwing you off. Pretend the little colour boxes are underneath the writing, not on top of it. That might help you.
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- Ann: FDA Strategy and Regulatory Update
To re-write this for all you over-eager investors:Day 1. Submit...
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