an inhaler that’s different than the typical asthma inhaler that blasts particles into the back of your throat. MAP’s technology, which is proprietary, enables its drug to be “breath synchronized,” in Nelson’s words. This means patients can breathe the drug in at their own pace, rather than time their inhalation with pressing the button on the inhaler, Nelson says.
Data on usability of the MAP inhaler was gathered from clinical trials, and included in the original application 10 months ago, but it was put together in four different parts of the voluminous application, Nelson says. Late in the review process, Nelson says, an FDA staffer made a request to the company to put all the data in one place so that it’s easier to review, Nelson says. He says the data in the Levadex application is strong, with more than 1,000 patients studied in trials, encompassing 10,000 headaches. [Correction: 4:45 pm 3/30/12] MAP found that 96 percent of patients in an ‘instructions-for-use’ study were able to take the drug properly without any external aid. [Editor’s note: an earlier version of the story said the 96 percent figure applied to the 1,000 patients across MAP’s clinical trials, when it should have been in reference to the smaller “instructions-for-use” study.]
Ultimately, this is a story that will say a lot about MAP’s credibility. Investors have to take MAP’s characterization of the FDA’s concern at face value, because the agency’s “Complete Response Letters” aren’t public records. But if MAP’s interpretation of the letter is consistent with that of the FDA, then shareholders have good reason to believe the delay will be measured in weeks or months, not years.
One thing is for sure. If this regulatory delay does end up dragging on, then MAP will no longer be able to consider itself one of the lucky biotechs getting the benefit of the doubt.
