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.
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
"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."
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."
According to these FDA rules, a company with a drug application acceptable for resubmission hears back from the agency within 14 days. If FDA continues to have problems with a resubmitted drug application, the company will also be informed but not necessarily within 14 days.
Navidea heard back from FDA in 14 days that the Lymphoseek resubmission was accepted. MAP Pharma is now on Day 29 of not hearing anything from FDA about the Levadex resubmission.
Levadex is an inhaled formulation of DHE, a drug already used in intravenous and nasal spray formulations to treat migraines. MAP Pharma developed a device that allows patients suffering from acute migraines to inhale the drug into their lungs, thereby accelerating pain relief.
FDA rejected Levadex in late March for what the company claims were outstanding problems related only to the manufacturing process for the device. The FDA did not raise safety concerns, including the possibility that migraine sufferers inadvertently take more than one Levadex dose at a time, MAP Pharma claimed. After meeting with FDA in June, MAP Pharma said it had all the data necessary to resubmit Levadex without needing to conduct new clinical trials or making additional refinements to the device.
MAP Pharma has been embroiled in FDA controversy in the past. The company had long claimed Levadex clinical trials were conducted under a Special Protocol Assessment (SPA) agreement with FDA. But later, MAP Pharma was forced to acknowledge that no Levadex SPA existed.
-- Reported by Adam Feuerstein in Boston.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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