This pattern has been occurring frequently. Companies receive approvable letters and there is no indication from the PR whether the approvable is a Class 1 or Class 2. So the question is, are the companies not relaying the FDA's message? or is the FDA not communicating their intent?
Insm, Ency and now NBXI. There are probably more, but my breadth of companies is not as wide as some of the others on this board. Is the FDa leaning towards first round "approvables" as a way of evading the PDUFA date?
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