http://www.globenewswire.com/news-release/2020/06/29/2054576/0/en/Intercept-Receives-Complete-Respo
nse-Letter-from-FDA-for-Obeticholic-Acid-for-the-Treatment-of-Fibrosis-Due-to-NASH.html This was not expected. First Genfit's Phase 3 trial failed, and now Intercept gets a CRL. "Uncertain" benefit. .. "does not sufficiently outweigh the potential risks." Lipocine's LPCN 1144 utilizes a known molecule (which is why they were able to skip Phase 1 and toxicity studies) with a safety profile acceptable to the FDA (see the recent approvals of TRT drugs XYOSTED and JATENZO).