Boston, MA 04/02/2014 (wallstreetpr) – After facing a fall in the business MannKind Corporation (NASDAQ:MNKD) is all set to make the right decisions and rectify all it’s mistakes to be back in business.
FDA Shows Concerns Over Afrezza
The FDA has shown its concern over the MannKind Corporation (NASDAQ:MNKD) produced Afrezza. Reportedly they are having speculations about certain pharmacological issues that could impact the safety and effectiveness of Afrezza. Apparently FDA is apprehending that the drug might have some potential risks like pulmonary function decline in patients having a lung disease or bronchospasms. The health regulators in the U.S. namely the U.S. Food and drug administration had previously rejected the new drug application for Afrezza and demanded that MannKind conduct two more clinical trials.
The Missing Data Concern
The FDA again showed concern over the missing data regarding Afrezza.
Clearing the Air Over Afrezza. The history of Afrezza has always been controversial due to the multiple deficiencies that have been pointed out in its application in the past. In fact two previous reviews of the Afrezza also resulted in the issuance of Complete Response Letters March 2010 and January 2012. Therefore the concerns that FDA has come up with are somewhat justified.
Clearing the Air Over Afrezza
Reportedly, the first two response letters, which were issued, previously were a consequence of the same mistake regarding Afrezza, which now has been taken care of. Sources say that sooner than later Afrezza will be approved because MannKind has met all the conditions of the FDA and met the primary endpoints.
The good news is that MannKind Corporation (NASDAQ:MNKD) has decided to cooperate with the FDA on their instructions regarding Afrezza and are all set to conduct the trials correctly. They already have a record of a clinical trial that was done correctly. The mistakes that the Company is reported to have made during the earlier trials was of switching the inhaler devices in the midst of the clinical trials. The Afrezza Clinical program, which included around 6,500 patients and the results were favorable.