MAP Pharmaceuticals, Inc (MAPP)

[surf1944]

7:25AM MAP Pharma trades down ~30% to 12.00 in the wake of Complete Response Letter on Levadex (MAPP) 17.14 : As mentioned last night, the FDA requested that the Company address issues relating to chemistry, manufacturing and controls and observations from a recent facility inspection of a third party manufacturer, but did not cite any clinical safety or efficacy issues, nor did the FDA request that any additional clinical studies be conducted prior to approval. Co is holding a call at 8:00 ET.

1:08AM MAP Pharma receives complete response letter from FDA for LEVADEX (MAPP) 17.14 : Co announces that the FDA has issued a Complete Response letter to its New Drug Application for LEVADEX inhalation aerosol. In the Complete Response letter, the FDA requested that the co address issues relating to chemistry, manufacturing and controls and observations from a recent facility inspection of a third party manufacturer. The FDA also indicated that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA. The FDA did not cite any clinical safety or efficacy issues, nor did the FDA request that any additional clinical studies be conducted prior to approval. The co is pleased with the FDA-provided revisions to product labeling and packaging, including correct use of the LEVADEX trade name. The co continues to pursue approval of LEVADEX for the acute treatment of migraine in adults and plans to request a meeting with the FDA to discuss the issues raised in the Complete Response letter.