According to Fool.Com, treatments such as MannKind's have had tough campaigns before, and both Eli Lilly (NYSE: LLY) and Novo Nordisk dropped their attempts several years ago. MannKind's palm-sized inhaler looks to be a better fit than the larger version offered by Pfizer (NYSE: PFE) and Nektar Therapeutics (Nasdaq: NKTR), but complicating MannKind's efforts is its inability to find a marketing partner. It hoped to have one on board before year's end but ended up admitting it will have to wait until its gets approval before seeking one out.
Jennifer Cummings of Dow Jones Newswires reports that, Oppenheimer analyst John Newman said his firm didn't believe that MannKind has started label discussions on Afresa with the U.S. Food and Drug Administration.
MannKind submitted a new drug application to the FDA for Afresa in May, and expects to get a decision from the agency by Jan. 16.
In Oppenheimer's view, the lack of label discussions this late in the review process suggests a complete response--as opposed to an immediate approval--may be inevitable, while MannKind Chief Financial Officer Matthew Pfeffer said that he was prohibited from commenting about the status of the label discussion, he did say that MannKind is in "frequent discussions" with the FDA.
"Had anything occurred in those discussions--including delays over the status of the label, or any other issue--we would have made an announcement to that effect," Pfeffer said.
Readers of BioMedReports flooded email boxes with angry notes like this one:
"What has just happened is a bear raid executed to perfection. Those with stops who are on holiday will find themselvees stopped out just like DNDN 10 minutes before it was halted. This is biotec manipulation at its worst"
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