Trilogy1 Phase3 Studie verfehlt primären Endpunkt

"As stated above, Acasti believes that existing cash plus the recent exercise of warrants will fully fund the Company’s operations beyond the completion of our Phase 3 clinical trials through at least June of 2020. Acasti will need to raise additional capital in the future to complete the funding of the preparation and filing of our NDA, and US commercial launch activities. If Acasti does not raise additional funds, it may not be able to realize its assets and discharge its liabilities in the normal course of business. As a result, there exists a material uncertainty about the Acasti’s ability to continue as a going concern and to realize its assets and discharge its liabilities in the normal course of business."

https://www.acastipharma.com/en/investors/...ss-update-for-the-second

https://www.acastipharma.com/en/investors/...ts-for-trilogy-1-phase-3

https://www.rttnews.com/3058391/...nusually-large-placebo-effect.aspx

https://seekingalpha.com/news/...pain-is-amarins-gain-up-12-premarket

Verzögerungen der TRILOGY2 Ergebnisse

https://www.acastipharma.com/en/investors/...-trilogy-1-and-trilogy-2

FDA fordert für TRILOGY2 eine Wirksamkeitsanalyse (und evtl eine weitere Studie)

"Acasti Pharma Inc., a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre^® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that the FDA has provided Acasti with a written response to its Type C Meeting request and briefing package.

The FDA confirmed that it will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat (ITT) population as contemplated in the original Statistical Analysis Plan (SAP), and they supported the conduct of post-hoc analyses in TRILOGY 1 for exploratory purposes. Consistent with the Company’s prior disclosures, and depending on the outcome of TRILOGY 2, an additional clinical study may still be needed prior to an NDA submission."

https://www.acastipharma.com/en/investors/...se-to-trilogy-1-briefing

TRILOGY 2 Phase 3 Studie verfehlt den primären Endpunkt

https://www.acastipharma.com/en/investors/...riglyceride-results-from

Prüfung strategischer Alternativen

https://www.acastipharma.com/en/investors/...e-brian-d-ford-cpa-ca-as