Ritter Pharmaceuticals Announces Phase 3 Plans for RP-G28

Ritter Pharmaceuticals (NASDAQ:RTTR) announced its phase 3 plans after their end-of-phase 2 meeting with the FDA for RP-G28 treating lactose intolerance.
As quoted in the press release:

The Company has incorporated guidance from the FDA on key elements of its Phase 3 program and received clear guidance and expectations on necessary components, including clinical, non-clinical, and chemistry, manufacturing and controls (CMC) requirements needed to support a successful NDA submission.
William Sandborn, M.D., Chief, Division of Gastroenterology at University of California San Diego commented, “The FDA meeting was very collaborative and constructive in helping the Company fully understand the agency’s objectives and expectations of the Phase 3 program. Having guidance and agreement on key clinical items such as screening methods to ensure an appropriate patient population, validated measures to capture appropriate clinical outcomes and well-defined endpoints for assessment, I believe the Company is well-positioned to enter Phase 3 trials to meet the FDA’s guidance on the expected clinical aspects needed for a successful NDA filing.”

Click here to read the full press release.

Source: www.marketwired.com