Former MannKind GCP Official Alleges Clinical Trial Fraud

Less than two months prior to the FDA’s user fee action date on its inhaled insulin Afrezza, MannKind is facing allegations of clinical trial improprieties from a former employee. John Arditi, MannKind’s former senior director of regulatory affairs, filed a lawsuit in a New Jersey state court against MannKind and several executives Sept. 16 alleging he was fired in retaliation for his insistence that MannKind alert the FDA to improprieties in Afrezza’s clinical trials. The suit was disclosed in a recent company quarterly SEC filing.
Clinical Trials Advisor