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rafunrafun

11/24/19 3:56 PM

#229844 RE: Atom0aks #229842

...however, the agency decided to defer to an advisory committee instead.

keep going, don't stop there... what did the majority (10-4-2) of the panel recommended, with regards to the primary prevention?

For more education, please see:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=152458341

jessellivermore

11/24/19 7:56 PM

#229901 RE: Atom0aks #229842

AtomO..

Whether or not the primary cohort showed significance is only part of the story...The R-I trial was not powered to detect significance in the primary cohort...The reality is that the primary cohort although being a smaller group than the secondary showed the same RRRs as the secondary...Its just there were fewer of them...And that is the reason the primary cohort should be included (and probably will be ) on the label..

The point was Vascepa was not less effective than the secondary group..the RRRs were basically the same...

":>) JL