SmurfVA's Random Picks

[SmurfVA]

ACST - ($1.23) Time to pay a revisit. Key notes below for those interested in re-entering/entering.

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.