Amarin Corp Plc (AMRN): GILD is taking a serious look at Vascepa...

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Biobillionair

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Sunday, 06/21/2020 11:00:11 AM

Sunday, June 21, 2020 11:00:11 AM

GILD is taking a serious look at Vascepa cohort in NASH trial. Study sites have expanded and results are now due November 2020.

GILD communicated earlier this year they would discuss pathway to approval after Cohort 12 &13....that cohort has finished....yet study runs until November.....;)

Guessing Cohort 12 expanded enrollment and move to 24 weeks after regulatory discussions with FDA regarding study and submission of NDA.

Experimental: Firsocostat + Cilofexor 30 mg + Vascepa® 4 g (Cohort 12)
Pre-treatment with Vascepa® (2 x 1 g tablet twice daily) from Day -14 to Day -1. Then, treatment with Firsocostat (1 x 20 mg tablet once daily) + Cilofexor (1 x 30 mg tablet once daily) + Vascepa® (2 x 1 g tablet twice daily) for 6 weeks

November 2020 - 24 weeks = mid May

Mid-May was the expect results of cohorts 12&13.

BB

https://clinicaltrials.gov/ct2/show/NCT02781584?term=Vascepa&draw=2&rank=24

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