FDA staff review raises questions about MannKind diabetes device
By Toni Clarke WASHINGTON (Reuters) – A review of MannKind Corp's experimental inhaled insulin device by U.S. Food and Drug Administration staff raised questions about its safety and effectiveness but was less damning than some investors had expected. The company's shares initially rose as much as 10.6 percent before falling back amid conflicting opinions from analysts on how the FDA will likely rule. The reviewers issued their report ahead of a meeting on Tuesday of outside advisers to the FDA, who will discuss clinical trial data and advise on whether the product, Afrezza, should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does so.