An easy question, yet MAP Pharma execs refused to answer! [But not before a long, awkward silence.]
Tang's question was brilliant. The narrative MAP Pharma was pushing Tuesday (and admittedly, quite effectively) was that FDA's lingering Levadex concerns were minor and easily fixed. If that's true, the complete response letter was more than likely relatively short -- a few pages, give or take.
Why, then, wouldn't MAP Pharma disclose the number of pages in the complete response letter? If the FDA's letter was actually quite long and detailed, it goes against the "no worries" message the company was trying to push across to investors.
Ron56 emails, "Your questions to MAP were overly aggressive and smacked of unprofessionalism. It sounded like you were doing the bidding of the shorts."
"Biotech Toreador" writes, "Excellent questions! Glad to see real questions not asked by sycophants depending on banking handouts."
I can't please everyone, apparently.
Paul B. asks, "When do you think Levadex can be FDA approved now?"
It's hard to nail down a timeline but here's a guess: MAP Pharma first needs to meet with FDA to discuss the Levadex rejection. Let's say that meeting occurs in late May or June. If all goes well, MAP Pharma resubmits in July or August after which the FDA takes six months to review the new data, which pushes the next approval decision date to January or February 2013.
Broadly speaking, under the most ideal situation, Levadex's launch is delayed by a year from the second quarter 2012 to the second quarter 2013.
Color me skeptical. I'm still not convinced FDA is as sanguine about Levadex as MAP Pharma wants us to believe. The usability issues surrounding the inhaler could still trip up and significantly delay approval -- specifically, concerns about what happens to patients who may inadvertently take more than a single dose at one time.
Charles T. emails, "
gets approved but the stock trades down. Is this the normal reaction? What am I missing?"
Of the FDA decisions this week, Affymax's Omontys was the most likely to be approved, so you're definitely seeing some sell-on-the-news following Tuesday's mid-day approval announcement. At $12 per share, Affymax's market value has doubled this year.