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 Kiwi