MOUNTAIN VIEW, Calif. (
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.
"When he have learned about our [Levadex] filing status, we will update the market via a press release," said MAP Pharma spokeswoman Lisa Borland in an email Monday night.
MAP Pharma executives spoke at an investor conference Tuesday without providing a substantive update on status of the Levadex resubmission. The company is expected to present at another investor conference Wednesday.
(NAVB - Get Report)
showed how the resubmission and acceptance process is supposed to work. On Oct. 31, Navidea resubmitted a once-rejected approval application for Lymphoseek, a lymph node diagnostic agent, to FDA. On Tuesday night, 14 days later, Navidea announced FDA had accepted the Lymphoseek resubmission.
Like any bureaucratic government agency, the FDA has a manual spelling out the rules and policies by which it's supposed to classify resubmissions of new drug applications that have been previously rejected.
This FDA manual, titled
Classifying Resubmissions of Original NDAs, BLAs and Efficacy Supplements in Response to Action Letters
"The review team and division director will determine the classification of the response, and a letter will be issued to the applicant acknowledging receipt of the resubmission
within 14 calendar days
stating the classification of and the due date for action on the resubmission." [Emphasis added.]
The FDA manual also states, "If CDER does not agree that the submission is a complete response addressing all deficiencies in the complete response letter, the applicant will be so informed, and the review clock will not start until a complete response is received."