Spiral Therapeutics (http://ift.tt/2xooDek), a pre-clinical stage company developing first-in-class therapies targeting inner ear disorders, has received positive feedback from the U.S. Drug and Food Administration (FDA) regarding its first Pre-Investigational New Drug (Pre-IND) package submission. The FDA answered Spiral's product development questions related to manufacturing and non-clinical testing, and concurred with the company's clinical development plans for its LPT99 program for preventing chemotherapy-induced hearing loss in pediatric patients. Pre-IND is a program through which the FDA's Office of Antimicrobial Products could provide advice on drug development before it begins. Spiral plans to raise additional funds for an initial Phase 1 trial, the development of new preclinical data, and the company's operations for the next 18 months.
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