Another scenario is also the Pdufa date has been extended for a further three months. (but a very late call in the game of things if this is the case)Just Looking at the latest few novel drug approvals, two were pushed back by three to six months to make a decision.Vanflyta/ Quizartinib - "The PDUFA date was extended by three months to July 24, based on an April 20 company announcement. Nonetheless, the agency did not require further efficacy and safety data in the application."
Ngenla / somatrogon-ghla - also seems to have been extended on more than one occasion
This is only looking at approvals also. In other circumstances, the three months seems to be a common practice by the FDA.
Another scenario is also the Pdufa date has been extended for a...
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