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Re: ramfan60 post# 423129

Tuesday, 04/09/2024 4:07:34 PM

Tuesday, April 09, 2024 4:07:34 PM

Post# of 426856
Ram et al. First any new version of Vascepa has to be bio equivalent to existing . FDA will want a short trial to make sure the new formulation has the same / similar side effects as original ...especially re Afib.
Second ...smaller, less pills for same clinical benefit is a huge marketing benefit ...especially if priced competitively with the existing .
Third. Pill burden is real . Many patients are required to take up to a dozen pills per day ...especially CKD patients that need to control serum phosphorus as well as their lipid profile.
All of this ( new formulation , competing against generics , pill size and number etc ) is playing out right now with UNCY and their drug OLC . Their final trial is underway ..results due late June 24 .
Suggest you look at that Ihub board for a road map if you think AMRN is likely to do down the " new formulation to compete against generics " road in the US .
JMO
Kiwi
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