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