does anyone know if you can find an offical transcript of what the FDA said ...... having said they will give approval without a control arm because it was unethical to this Children, in setting the guidelines for a trial in 2016 or 2017?
it is a major statement. This was mentioned in a MSB industry presentation in referring to FDA feedback.
Not fully discussed in the 9-1 vote nor FDA currently.
MSB to dispute FDA finding in Type A meeting, page-586
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