InvestorsHub Logo

genisi

10/03/17 4:40 PM

#214045 RE: RockRat #214032

RDHL -13%

Another possible disappointing point from their PR:

In addition, following a successful first Phase III study and a positive guidance meeting with the FDA, RedHill is designing a confirmatory Phase III study to support a New Drug Application (NDA) for BEKINDA® 24 mg for acute gastroenteritis and gastritis

There was an expectation they might file an NDA without additional study or with a post-marketing study but they need a confirmatory Phase III study.