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Friday, 08/09/2019 11:24:12 AM

Friday, August 09, 2019 11:24:12 AM

Post# of 423948
I'm sorry can some long timers please respond?

I was not here in 2013, and I'm seeing anxiety about the Adcom and how AMRN was "ambushed" by this particular panel with FDA's help. Can I ask a few simple questions for clarity?

1. At the last Adcom were we represented by Dr Bhatt?
2. At the last Adcom had we completed a 5 year 8000 patient CVOT done hand in hand with FDA?
3. At the last Adcom had the materials been peer reviewed by NEJM?
4. At the last Adcom had Vascepa been reviewed by ICER?
5. At the last Adcom had Vascepa been named standard of care by the American Diabetes Association?
6. At the last Adcom did you have the same number of patients safely using Vascepa without SAE's as you do now?

Of course I'm being a bit sarcastic here but I'm trying to make a point.

So many long timers got stung they seem now to not see the difference.
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