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ziploc_1

08/29/19 4:31 AM

#211694 RE: alm2 #211692

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

Biobillionair

08/29/19 7:13 AM

#211700 RE: alm2 #211692

Good post and everyone should read it. BB