OvaScience (OVAS) shares plummet 38% after the FDA said the company has to file an Investigational New Drug application for its lead product, Augment, which is designed to increase IVF success rates.
The FDA has doubts about the status of Augment as a human cellular tissue-based product (HCT/P), which isn't subject to the same scrutiny as a new chemical entity and so can avoid years of trials to gain FDA authorization.
OvaScience has halted a U.S. study of Augment and will focus on trials outside the country, which are slated to start in 2014.
The company plans to hold talks with the FDA but its hopes of launching the treatment in the U.S. by the end of next year are looking rather forlorn. (PR)