Will MannKind Corporation (NASDAQ:MNKD) Get Approval From FDA?
MannKind Corporation (NASDAQ:MNKD) announced on October 14th, 2013 that it will be asking federal FDA to approve the marketing and even sales of their inhalable insulin powder and the name they have chosen is Afrezza. It is important to mention that FDA had initially declined the application put forth by the company two years back.
MannKind Corporation (NASDAQ:MNKD) released an official statement stating that it had filed the paperwork on Sunday itself. They are of the opinion that Afrezza is so made that it can help in improving the glycemic levels in patients suffering from type-1 and even type-2 diabetes as well.
MannKind Corporation (NASDAQ:MNKD) has been in the R&D phase ever since it was found by Alfred Mann and they do not have any products that is currently marketable. When the applications were denied by FDA two years back, FDA had stated that the product needed a lot more clinical trials. After the denial, the share price of the company dropped significantly. Recently, there has been a slight increase in the prices and this was largely due to the extra finance that was arranged by their billionaire investor.
MannKind Corporation (NASDAQ:MNKD) believes that they have done their part of the additional trials and are ready to go. Their phase three trials in particular have yielded positive results and the CEO is hopeful that the company will finally manage to get the clearance and get its very first marketable product. The CEO has praised his team saying that he is proud of the achievement and also applauded them for sticking to the schedule and keeping an eye on important points like safety of the drug and so on. The CEO told that they will continue to work with the FDA and will release their product in the market because it is likely to help a lot of diabetics in the U.S.