CHARLOTTE, N.C. ( Stockpickr) -- On Aug. 14, MannKind ( MNKD) reported long-awaited positive phase III results from two clinical trials of its Afrezza insulin and inhaler product. Now the company finds itself faced with a fascinating mixture of positives, negatives and uncertainties, guaranteeing that MNKD will be an excellent trading stock -- with the whipsaw price-movements so dearly loved by traders -- for the foreseeable future.
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But couldn't MNKD also represent an exceptional
right now, as well?
Let's look at it from both angles, after neatly categorizing the positives, negatives and uncertainties.
1. Clinical trials for both type 1 and type 2 diabetes patients met the primary endpoints sought by the company and, presumably, the FDA.
2. Afrezza, by itself or in combination with an oral insulin product, was well-tolerated by nearly 100% of participating patients.
3. The trials showed that Afrezza, by itself or in combination with an oral insulin product, may well reduce or eliminate many diabetics' reliance on injected insulin.
4. As the FDA has, in the past, already approved Exubera -- widely perceived to be an inferior product compared to Afrezza -- FDA approval of Afrezza in early 2014 should be a near-certainty.
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5. Exubera was pulled by
) in 2007, so if approved by the FDA, Afrezza will hold an absolute monopoly on the inhaled-insulin market, which many believe to be initially worth $3 billion yearly.
1. Approximately one-third of patients participating in the Afrezza clinical trials experienced, as a side effect, a mild cough and a slightly lessened exhaling power of the lungs.
2. A greater number of Afrezza patients experienced low blood sugar, compared with patients using injected insulin.
3. Doctors have for many decades been totally familiar with the use and prescribing of injected insulin. Afrezza will be totally new to them, with regards to dosage, performance, side effects and so on.
4. Exubera, Pfizer's inhaled-insulin product previously approved by the FDA, proved to be a commercial failure, losing $3 billion for that company and leading them to pull out of the market after only one year. Many fear that AFREZZA may suffer a similar lack of commercial success.