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Re: DewDiligence post# 211178

Thursday, 06/01/2017 10:35:50 AM

Thursday, June 01, 2017 10:35:50 AM

Post# of 251670
OCRX starts phase-2a trial for oral formulation of OCR-002 in cirrhotic patients—results expected by year-end:

https://finance.yahoo.com/news/ocera-initiates-phase-2a-study-130500660.html

The Phase 2a portion of the trial is an open-label, multiple-dose, randomized, 3-period crossover study. It is designed to evaluate the steady-state pharmacokinetics and pharmacodynamics of three times daily administration of three daily dose regimens, 6, 12 and 21 grams, of OCR-002 tablets in 18 patients with Child-Pugh B cirrhosis. We expect to complete the trial and report top-line results by the end of 2017.

Meanwhile, OCRX will meet with FDA on how to proceed with the IV formulation (#msg-131214002).

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