|Company Name||Aradigm Corporation|
On January 9, 2018, the U.S. Food and Drug Administration (“FDA”) released its briefing document for the January 11, 2018 meeting of the Antimicrobial Drugs Advisory Committee to discuss the New Drug Application for Linhaliq™ for the proposed indication of treatment of non-cystic fibrosis bronchiectasis (“NCFB”). The FDA stated that “there were too many uncertainties with regard to duration of treatment, frequency of administration and endpoints to allow for reliance on a single Phase 3 trial” of the drug, and that the FDA recommended Aradigm conduct “two independent trials” to provide evidence supporting the drug’s “overall demonstration of efficacy and safety.”
On this news, shares of Aradigm fell significantly, thereby injuring investors.
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