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grbnitz4002

03/19/19 8:56 AM

#181798 RE: BioChica #181796

Or is our management team pushing to get an immediate approval of our Anchor indication,with the Billions of $'s that come with that, the immediate increase in value to our European partner, and an immediate boost to our GIA strategy.
Increased indications to come after we've shown BP the door?
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SocialBoom

03/19/19 8:58 AM

#181800 RE: BioChica #181796

JT is brilliant. They/he is going for the layup. Expanding the label to Triglycerides >150 is the lane the FDA has basically no hurdles on based on the SPA of Reduce IT and expands the market to the point supply will be an issue in 2020. Once complete everything else is on the table. No distractions.
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rfj1862

03/19/19 10:33 AM

#181821 RE: BioChica #181796

Maybe these Cardiologist's aren't so smart. We have been through AHA and ACC and not a mention of EPA/AA ratios.



You aren't hearing about it because it isn't important. Nobody cares about surrogates when you have clinical outcomes.
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sts66

03/19/19 3:30 PM

#181897 RE: BioChica #181796

JT has no business talking about EPA/AA ratios - he's a CPA, not a doctor - leave that to Dr. Bhatt. I think AMRN is staying away from that (yes, they measured EPA and AA in R-IT) to keep this simple for the FDA - just depend on the outcomes data to get the expanded label, don't go throwing MOA theories around until you have semi-definitive proof that the theory may be accurate. I think they're studying and analyzing ALL non-lipid biomarkers, especially inflammatory markers, to see how they correlate with outcomes, and that research is going to take time to come up with good conclusions - that data might help support JL's theory of SI being root cause of CVD. I sure hope they come up with that data, because SI is why I'm taking V - I believe it's helped me greatly, have some proof via weight loss, much less muscle pain/problems, and some blood test results, but unless I never have a CVE I won't know if V reduced my risk or not - and I was very high risk when I started taking it.