Call It an "Almost Approval"

As my grandfather used to say, close only counts in horseshoes, hand grenades, and Food and Drug Administration approvals.

MAP Pharmaceuticals (Nasdaq: MAPP  ) traded down just a little today, after the FDA sent the biotech a complete response letter -- the agency's euphemism for a rejection -- for its migraine treatment Levadex. The FDA cited three issues with the application, but they all seem addressable.

First, the biotech submitted information about patient usability of the Levadex inhaler during the review, which the FDA hasn't had a chance to look at. If it was just that issue, the FDA would probably have pushed back the approval by three months, but given the other issues there was no need to delay a decision for an inevitable rejection.

There are also issues at a third-party manufacturer that fills the can for the inhaler, but management said the manufacturer had already responded to the FDA about the issues or that they're easily addressable, so it doesn't seem like a major issue. A reinspection, which could delay the eventual approval, might not even be required.

The biggest unknown has to do with issues relating to chemistry, manufacturing, and controls. Manufacturing is always a black box for investors, and the management wasn't willing to give more information about what exactly the FDA wants, although it did say that it probably has the data in hand.

It's what wasn't in the letter that should be relieving investors' headaches. There were no issues with safety, efficacy, or mode of delivery, the issue I was worried it'd be tripped up on. Management even mentioned multiple times that it was discussing the label and packaging with the FDA, which usually doesn't occur until the FDA is sure the drug is approvable, since it would be a waste of time otherwise.

I'm a little surprised MAP didn't pop a little after the rather muted rejection, the way Amylin Pharmaceuticals (Nasdaq: AMLN  ) and Alkermes (Nasdaq: ALKS  ) did when the FDA rejected Bydureon over minor issues the first time. Of course, with Discovery Laboratories' (Nasdaq: DSCO  ) manufacturing issues -- and four rejections before finally gaining approval -- fresh in investors' minds, perhaps they're worried this won't be resolved quickly. And of course, even if the issues are easy to clear up, there's nothing stopping the FDA from finding something new on the next review, such as with what happened with Bydureon.

Still I'd see this as a buying opportunity for MAP. To track my prediction of an approval, I made an outperfom CAPScall on Friday, and I'm sticking with that call for now.

Investors looking to make a real-money call have plenty of time to get in though. It could take 60 days for MAP to get a meeting with the FDA, and then figure a few months to gather the data to answer the FDA's questions. After resubmission, the FDA will classify the review as a Class 1 or Class 2 response, resulting in a two-month or six-month review, respectively. Given that the agency will have to review both CMC data and the usability data, I'd expect it to be a Class 2 response, so figure an approval in about 10 months.

While you're waiting to see whether Levadex gets approved on the second attempt, take a look at what Fool analysts believe is the next rule-breaking multibagger. Get the free report.

Fool contributor Brian Orelli loves it when he guesses wrong and his CAPS score doesn't go down. He holds no position in any company mentioned. Check out his holdings and a short bio. The Motley Fool has a disclosure policy. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.

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  • Report this Comment On March 28, 2012, at 9:59 AM, philsie2 wrote:

    Are you serious?!? Whether or not they eventually get approval doesn't mean much right now. This is a minimum 10-month delay for approval and buyers NEVER look favorably on delays. Thus, I'd say that you have a very long opportunity to get in say a month or so before the resubmit (which will get a short-term pop) and then again a month or so before they get a response.

    Yes, I'm short. Been trading biotechs for many years and despite being overall positive on the long-term outlook this albatross is going to suppress interest for a while.

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