Acasti Pharma, Inc (ACST)

[morokoy]

Extract from AMRN latest 10Q.(End of August will soon be here.)

In January 2020, Acasti announced topline results of the TRILOGY 1 trial of CaPre. The study did not reach statistical significance and further analysis in underway. In April 2020, Acasti announced that it filed a meeting request with the FDA to discuss the TRILOGY 1 data and align on the interpretation of the results. Acasti also will seek FDA input on revisions to the pre-specified TRILOGY 2 statistical analysis plan, or SAP, and on a plan for pooling the data from TRILOGY 1 and TRILOGY 2 in support of an NDA filing. Acasti stated that it received a written response from the FDA in June 2020 confirming that the FDA will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat population as per the original SAP and supporting Acasti’s conduct of exploratory post-hoc analyses in TRILOGY 1, depending on the outcome of TRILOGY 2.

Accordingly, Acasti may be required to conduct an additional clinical trial before submitting an NDA. Acasti also stated that they expect to announce topline results of TRILOGY 2 at the end of August. NDA submission (if any) and resultant review/approval timelines will be announced following completion of TRILOGY 1 and 2 data analysis.