Acasti's open-label, randomized, four-way, cross-over, bioavailability study compared CaPre given as a single dose of 4 grams in fasting and fed states with the approved hypertriglyceridemia drug LOVAZA (omega-3-acid ethyl esters) in 56 healthy volunteers
So you think the FDA will allow this Co to quote you "skate thru "..?
Do they even have the money for a phase 3 trial ...and the FDA won't be interested in testing "healthy volunteers ".....not to mention the FACT that they FDA will require an Outcome trial if any reduction in CV events is claimed .
Whats the betting on a soon to be announced capital raise ... Kiwi
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