Advair generic delay negative news for Mylan, says Wells Fargo
Wells Fargo analyst David Maris notes that Mylan announced that it received an update from the FDA concerning its generic Advair application and the FDA has identified minor deficiencies that will be relayed in a Complete Response Letter on June 27. While noting that he does not know how long it will take Mylan to respond to the CRL, the analyst says the delay is negative news for the company, but less so from a financial basis than a sentiment basis. Further, Maris believes this delay is important as this is a high-profile product that may already be in market expectations, and the delay may take away some excitement about a near-term catalyst. The fact Mylan said it will determine after getting the CRL whether this has any impact to its 2018 outlook, also creates some uncertainty, he contends. Maris reiterates a Market Perform rating on the shares.