Very transparent. Every time MNKD goes against the shorts, they publish a story disguised as a report. This time they are really reaching. Do they really think that people are that stupid to be influenced by this #$%$?
• The FDA has tentatively scheduled an Endocrinology & Metabolic Drugs Committee meeting for April 1st to review Mannkind's Afrezza. The PDUFA date is only two weeks after the meeting on April 15th, and that suggests to us that the intent is to discuss the drug's label.
• The timing is closer to the PDUFA date than we would have liked to see, but it still leaves the agency with sufficient time to render a decision within its statutory deadline.
• This is GOOD NEWS, as we believe the panel meeting is an indication the agency is prepared to approve Afrezza. Why else would they have to be advised on the appropriate patient population for insulin? The FDA has already asked the Company to conduct a post-marketing study of Afrezza in children as young as four years old, which clearly means they have little concern over safety. Indeed, Mannkind submitted a risk management plan years ago that apparently met with the agency's satisfaction. Moreover, efficacy has been demonstrated multiple times in patients requiring basal and prandial insulin, and the Affinity 2 trial that was designed with the FDA's guidance showed Afrezza is effective in controlling a type 2 diabetic's glucose levels when added to a regimen of oral antiglycemic agents.
• We believe TODAY'S PRICE WEAKNESS HAS CREATED A BUYING OPPORTUNITY. In the past few weeks, the stock has been benefited from speculation over approval, and while the volume achieved yesterday is probably not going to be seen again at least for some time, we think the general upward trend will continue.