Wall Street Maintains Positive Bias on MAP Pharmaceuticals (MAPP) Despite Levadex Setback

Analysts are out defending MAP Pharmaceuticals (NASDAQ: MAPP) this morning after the company received a complete response letter (CRL) from the FDA for Levadex. The CRL identified issues related to chemistry, manufacturing, and controls, but importantly did not cite any clinical safety or efficacy issues or request any additional clinical studies.

Analyst Comments:

• Deutsche Bank - Reiterate Buy rating and price target of $20. "Based on the limited information available, we see a potential four month (best case, including Class 1 two month review upon resubmission) to 12 month (worst case, including Class 2 six month review upon resubmission) delay in final approval for Levadex. Moreover, there are a couple other variables that could impact the company's outlook/valuation in the near term-- MAP currently does not have a primary care (which accounts for 80% of US migraine Rxs) or international partner to promote Levadex. Given what appears to be a delay in commercialization, the timing of PCP/international partnership(s) could now come either before or post Levadex approval--vs our prior expectation of potential partnership(s) post approval."
  
• Wedbush - Reiterate Outperform, $30 target. "We are encouraged by the language in the complete response letter and MAPP’s press release that remaining issues leading to the CRL did not include clinical safety or efficacy issues or a request for more clinical trials which could have significantly delayed approval. Instead the FDA reviewer’s issues leading to the CRL included "chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer". These issues are likely to be minor and easily corrected. We believe the core issue was the inability of the FDA to complete the review of a last minute request for information on "inhaler usability".

For an analyst ratings summary and ratings history on MAP Pharmaceuticals click here. For more ratings news on MAP Pharmaceuticals click here.

Shares of MAP Pharmaceuticals closed at $17.14 yesterday.

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