NanoViricides receives favorable FDA comments on lead drug candidate
NanoViricides that it has received favorable comments from the U.S. FDA on the company's pre-IND application for its lead drug candidate. The company reports that the U.S. FDA has generally agreed in its pre-IND response that the plan of drug development presented by the company to the FDA is generally adequate at this time. The company received the response on May 23. In particular, the Agency has agreed that the company's strategy for drug substance and drug product acceptance criteria is adequate. The Agency has further agreed that the IND-enabling non-clinical studies proposed by the company are generally adequate. The U.S. FDA also said that the proposed design of the IND-opening human clinical studies appears reasonable at this time.