Great find @FullMoonFever.
I think the summary is generally on our side with just one extra piece of info that covers the first statement;
"Conclusions and RelevanceAvailability of multiple trials is associated with higher odds of ODAC recommendation and drug approval. Availability of randomized data appears less important."
The extra info is there are no approved treatment for younger pediatric patients. I might be naive but I believe the person speaking on behalf of the children who need treatment will negate the need for mulitiple pediatric trials, and if the idea has not been put to bed on ethics grounds already, a RCT pediatric trial, that person being;
From https://www.fda.gov/media/140999/download
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- FDA ODAC Meeting Material discussion analysis
FDA ODAC Meeting Material discussion analysis, page-188
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