mcstuffins will be interested to hear this. he has been saying for years that aa only happens during a trial, based on surrogate endpoint and therefore we needed another trial.
appears this isnt the case. and why should it be when we already have the mortality. so in this case aa with existing data, is more like a conditional aprroval but fda does not use the term conditional.
Presentation on ASX Gems Conference on 21st June, page-134
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