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Word On Wall Street: Mylan Receives Non-Approval On Advair; What Now? Mylan received a non-approval from the FDA on their Advair generic; while somewhat expected, the results were disappointing to investors. Management's guidance for the year is now in question; most investors do not expect the drug to receive approval in 2017 now. Investors are now grappling with what may have led to the non-approval (no details yet disclosed) and whether management will be able to hit 2017 targets. As I had written previously, Mylan investors were anticipating the upcoming action date on their generic drug for Advair on March 28th. Generally, the consensus anticipated a likely delay (which would probably send the stock down 2-3%), but left open the possibility for a surprise approval (which would have maybe sent the stock up 10%). As a whole, however, the consensus also anticipated that the drug would likely get approved some time in 2017, and consensus 2017 EPS estimates (as well as management's guidance) baked in some degree of Advair-generic revenue. Here's what happened when the results were released a day later, intraday: The company received a CRL (complete response letter), which is essentially a non-approval from the FDA. Mylan (NASDAQ:MYL) stated that they would review the letter and provide an update after reviewing and discussing with the FDA. What does this mean for the stock? - Mylan hasn't provided any details about the CRL so it's difficult to say just how long the Advair-generic approval might be delayed. It could be a minor thing that could be fixed quickly, or it could drag on for awhile (if there are manufacturing deficiencies, for example). - In general, most investors seem to think that it is likely going to drag on for another 9-12 months (and therefore is likely to move into 2018), based in part on the Copaxone-generic experience, but also in part on the complexity of the application. But really, we won't know much more until Mylan discloses more details ar