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Re: jfmcrr post# 208815

Wednesday, 08/14/2019 2:04:07 PM

Wednesday, August 14, 2019 2:04:07 PM

Post# of 423948
jf. Read AVII's posts linked by Raf .

There is a risk of withholding treatment if some data supports likely benefit.... but the data is not robust enough to justify on a stat sig basis .

IF Adcom was to place any weight on the JELIS data ...which was mostly primary prevention ....that could move the needle towards a primary prevention label.

Theres also a risk / benefit consideration . Extremely low risk and reasonable exception of benefit ..
I don't think its probable ..primary prevention label.....but it's certainly possible if you read AVII's opinion
JMO
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