Saturday, April 06, 2019 4:14:06 PM
Link to the conf call transcript with the two trials end of 2019 is here
Acasti Pharma, Inc. (ACST) CEO Jan D'Alvise on Q3 2019 Results - Earnings Call Transcript $ACST https://seekingalpha.com/article/4241617
I do believe both companies will piggy back the epa levels. The lovaza argument is a lost cost bc they won’t get the same epa levels and have failed outcomes trials.
However for MTNB, with epa and dpa if their biomarker trial succeeds head to head and they get better epa blood levels then Vascepa, They believe they have an avenue for fda approval if you listen to their conf call. If amrn claims a certain epa/aa ratio as the pt population that benefits, and MTNB drug can get the pt population and raise epa levels better that will be their argument. Mind you end of 2020 read out. Also will take few years for approval. Problem is MTNB has people formerly at fda working for them as well as steering committee members of strength trial and reduce it working for them. Very experienced.
As far as ACST, I think they need a strength trial positive read out to be a true threat. If strength trial positive , then they have be able to claim epa levels as the key mechanism. They’re phase 2 trial was against lovaza which isn’t the market leader.
Also remember this is how statins started. So many came to market without outcomes trials. They piggy backed.
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