ACST - ($1.33) Watching here to see if she can hold @$1.30s level. Most likely give her another go this week. Please note the underlined Clinical trials upcoming events. I will expect this to run again here.
Clinical Trials
Acasti continues to make significant progress in its research and clinical development program. Recently, Acasti announced that the FDA had given it clearance to initiate a PK trial in the U.S. This is a significant milestone and a key first step towards securing regulatory approval to distribute and market CaPre(R) as a prescription drug in the U.S. Quintiles, the world's largest provider of biopharmaceutical development and commercial outsourcing services, has been engaged to conduct the trial. The PK study is expected to start in the second quarter of calendar 2014 and results would be announced in the following quarter.
Going forward the Corporation intends to amend its initial PK Investigational New Drug submission with the FDA to also request approval to conduct a Phase III trial in the U.S. The amended submission should be filed by the end of February 2014.
Patient recruitment for the Phase II TRIFECTA study, a randomized, double-blind, placebo-controlled trial is on-going and special focus is being given to recruiting patients in the moderate to severe hypertriglyceridemia population (triglyceride levels over 500 mg/dL). The Corporation continues to aim for trial completion by the first half of calendar 2014. Based on the positive safety data found in the previously completed COLT trial, Acasti filed an amendment with Health Canada in December 2013, to broaden the inclusion criteria to facilitate patient recruitment for the above 500 mg/dL group. Depending on Health Canada's response, Acasti will adjust its strategy accordingly.
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