”would be required to conduct additional testing to PROVE its clinical effectiveness”
Yes, this is why phase 3 trials are mandatory before approval. That doesn’t mean that the previous phase 2b trial hasn’t shown efficacy. In fact if it hasn’t shown efficacy, you usually don’t proceed to a Phase 3 “proof” trial. SRP-9001 has SHOWN statistically significant efficacy in its phase 2 trial.
For General Information, page-1118
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