Friday, February 04, 2022 5:37:36 AM
1. A number of committee members referenced side effects of Vazkepa as, bleeding, fish oil flavored burping and constipation. Our company reps retort to this was that bleeding was not fatal. Fishy burping is an emotive symptom and we need to be able to push back better.
2. The Strength trial was referenced a number of times as a negative in association with Reduce-IT. Our company reps didn’t make it crystal clear that Strength trial is EPA and DHA as opposed to Reduce-IT being EPA only.
3. In defense of both Sabine and Hakima allot of technical questions on modelling of MACE outcome over 1,2,3 years came up which unless you were involved in the trail you would struggle to answer.
4. There were a number of outstanding points that AMARIN need to get back to the committee on before a decision on reimbursement is made.
a. One of these which our reps didn’t know was the time to discontinuation and what was the drop off rate after two years.
b. Sabine G of the ERG was looking for time to event analysis/subgroups which she said she hadn’t received (She did state she had just returned to work from holiday)
5. As a simple observation we had a main company rep who didn’t speak English as her first language attending a forum where all those who attended did have English as their first language. In light of the current political challenges with Brexit between France and the UK I wonder if this is our best approach.
6. Hakima was putting her physical hand up a number of times to make a point but the procedure was to “raise your hand” using the zoom emoji. I thought this was basic zoom etiquette that Hakima should have been aware off.
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