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ACST

Acasti Pharma

$0.58 /

-0.0044 (-0.75%)

08:14
02/14/20
02/14
08:14
02/14/20
08:14

Acasti Pharma reports Q3 EPS (18c), one est. (16c)

Jan D'Alvise, president and CEO of Acasti Pharma, commented, "We are making steady progress with the audit of TRILOGY 1 data and additional post-hoc analyses. This data has been very informative, and provided we have the FDA's support, any learnings we can take from this investigation that may allow us to adjust the Statistical Analysis Plan for TRILOGY 2, gives us a better chance of accurately reflecting the clinical value that we see in CaPre. As previously noted, we have confirmed that there is established precedent for the FDA accepting post-hoc analyses of study results, assuming the analyses are transparent, well justified and well supported. We are moving as quickly as possible now to complete this work and secure a meeting with the FDA. Until we have that important meeting, we intend to keep TRILOGY 2 blinded. Consequently, we now anticipate the unblinding of the topline results for TRILOGY 2 sometime in calendar Q3 of 2020, to allow time for the FDA meeting. Accordingly, key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 studies, would now be expected after the unblinding of TRILOGY 2 results. We are moving as quickly as possible and will provide material updates when available."

  • 14

    Feb

  • 19

    May

ACST Acasti Pharma
$0.58 /

-0.0044 (-0.75%)

01/13/20 Roth Capital
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Amarin should rally on failure of two potential competitors, says Stifel
01/13/20 B. Riley FBR
Acasti Pharma downgraded to Neutral from Buy at B. Riley FBR
12/24/19 B. Riley FBR
B. Riley FBR continues to like Acasti Pharma risk-reward going into 2020

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