I guess to simplify the logic.
Accelerated approval allows early release to market by using surrogate endpoints. These surrogate endpoints still have to be met by a trial.
Now, MSB has completed a trial already. And are now applying for accelerated approval.
You are suggesting they will use the data already gathered. But what would they be looking at?
You can't come up with endpoints after the fact and look back at the trial to see if they were met - science doesn't work that way. For statistical reasons.
A new trial will need to be designed for accelerated approval. That will have primary endpoints as well as surrogate endpoints.
There's no other way this could work. I'm keen to hear your suggestion @LearningEachDay
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