MAP Pharma's Awkward FDA Silence
MOUNTAIN VIEW, Calif. ( TheStreet) -- MAP Pharmaceuticals (MAPP) resubmitted Levadex to the FDA on Oct. 16 -- a second attempt seeking approval for the migraine headache inhaler after regulators issued a rejection letter in late March. Under the agency's rules, FDA has 14 days to accept a resubmission and assign a new approval date, which means MAP Pharma should have heard something by Halloween.
Twenty-nine days have passed since MAP Pharma resubmitted Levadex to FDA. One of two things has happened: The agency completely whiffed on meeting its review timeline, or FDA isn't going to accept the Levadex resubmission.
MAP shares, at Tuesday's $13.73 close, are down 11% since Oct. 31.
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