JP Morgan on MAP Pharmaceuticals Delayed Approval of Levadex

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JP Morgan has published a research report on MAP Pharmaceuticals
MAPP
after the company's FDA approval delay due to yesterday's complete response letter. In the report, JP Morgan writes, "[Yesterday] after the close, MAP announced that the FDA has issued a complete response letter (
CRL
) for the company's lead product Levadex (inhaled DHE, migraine). While we had expected a first-pass approval, we note that the FDA is not requesting any additional clinical trials and that the description of the remaining issues (related to manufacturing) appear manageable and we continue to view Levadex as an attractive, approvable product. Nonetheless, we expect the shares to trade lower as the key positive catalyst for the stock has now been delayed, and we will listen for an update on the potential timelines from here on the upcoming conference call." JP Morgan maintains its Overweight rating on MAP Pharmaceuticals, which closed yesterday at $17.14.
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Posted In: Analyst ColorNewsReiterationFDAAnalyst RatingsHealth CareJP MorganlevadexPharmaceuticals
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