In a note sent to clients, a harsh comment made by Hapoalim Securities analyst Jon LeCroy, stated that California based MannKind Corp. drug inhalable Afrezza (Insulin Human [rDNA Origin) will not be approved to treat Type I and II diabetes.

LeCroy´s comments are based on Phase III clinical trials results that were made partially public. According to data, Afrezza doesn’t keep a proper glucose level on a monthly basis, what’s known as “hemoglobin A1c.” Instead, the drug is good at maintaining blood sugar levels right after a meal, but its effects quickly fade as it has a “short half life.

During daily medical practice doctors don`t measure glucose levels right after a meal but only on average basis. According to LeCroy , Afrezza did not show effectiveness for Type I diabetes during standard measure, therefore makes it unlikely to be approved for treatment.

Last week during a conference call, the company revealed that Afrezza was superior to treat Type II rather than Type I, a tacit admission of the problem, in LeCroy’s view.

Meanwhile MannKind is waiting to meet with the FDA and LeCroy mentioned that it will be a long wait given that the FDA does not consider the drug a priority.
Last week the FDA sent a complete response letter related to a comparative chart necessary to evaluate differences of the product between the drug tested in clinical trials and the one that eventually will be marketed. 

At the same time LeCroy assured that although data for Type II treatment was not studied, the drug will not be approved for this condition.