Good morning Vire, there is no due date for a submission. The FDA implemented those timelines as a way of saying they are going to try and speed up approvals and to justify charging for ANDA submissions. These are just guidelines. To be honest from what I am seeing the approval times have increased but don't expect 10-12 months for approvals. I still have some drugs filed that are going on 4 years. Depends on what reviewers you get and what they find/want. In my experience most filings get a CRL, this is not bad especially if they are minors and not majors. Nas knows what he is doing and a lot of this is out of his hands and with the FDA. Its a waiting game and that is why he is filing more drugs. Build the foundation and revenues. This whole process just takes patience and I know we have been through a lot and waited a long time, but the beginning of the share price rise is coming as can be seen by the approvals. Good luck to everyone.
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