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Re: RockRat post# 214032

Tuesday, 10/03/2017 4:40:16 PM

Tuesday, October 03, 2017 4:40:16 PM

Post# of 251661
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.

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