Island Pharmaceuticals: Receives FDA feedback on clinical trial application

Island Pharmaceuticals Receives FDA feedback on clinical trial application

• Island Pharmaceuticals (ILA) receives additional FDA feedback after its IND application for a phase two trial of its ISLA-101 drug was put on Clinical Hold
• The letter from the US Food and Drug Administration noted the adjustments needed to the company’s protocol and application to advance the program
• The FDA says more data would also be required to support the proposed dosing regimen
• Island says it plans to obtain this data in a small, single-ascending-dose clinical trial that measures the blood concentration of ISLA-101
• IslandPharmaceuticals shares are trading at 15 cents at 3:37 pm AEDT