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Re: alm2 post# 211692

Thursday, 08/29/2019 4:31:35 AM

Thursday, August 29, 2019 4:31:35 AM

Post# of 427370
If the FDA really wants to get negative votes from the Adcom panel, they can always ask questions not covered by the R-IT SPA or by the sNDA...For example:

1. Do you definitely believe that Vascepa will be effective in causing a reduction in CVE in patients, not also on statins?

2. Do you definitely believe that Vascepa will be effective in causing a reduction in CVE in patients with Trigs of less than 70 mgm/ml

3. Do you definitely believe that Vascepa will be effective in diabetics without a history of a cardiovascular event and without any risk factors?

I hope this adversarial scenario never happens...as it did in the Anchor Adcom Ambush, in October 2013
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