It was never about the kids for FDA. Its always about the efficacy of an unknown theraphy for the FDA. The FDA has been unequivocal on what they wanted at the very start. The ODAC voted 9-1 in our favour based on the results...but that wasnt enough in Dec 2020. They wanted all in
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- FDA could approve it for the children
It was never about the kids for FDA. Its always about the...
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