Thanks for all the information @Phaedrus
One question: If MSB run an adult trial, wont the goal then be an Accelerated Approval or Full approval outcome and not ‘label extension’ status that MSB have mentioned they are chasing now?
If you think not, at what part of an Adult Trial would MSB ask for the label extension?
What are the data points required as a minimum to achieve the ‘Label Extension’ is the ultimate question.
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