Agreed that most generic-drug companies get their P-III ANDA’s submitted early enough to obtain tentative FDA approval before patent expiry. However, this doesn’t mean the slowness of the FDA reviews in these cases is entirely benign. The slowness incurs a hidden cost on the business model of the generic applicants by forcing them to commit capital to an ANDA program before they would need to do so if the FDA acted more swiftly.
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