The general understanding of Accelerated Approval
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Posted On: 05/02/2019 1:32:47 AM
The general understanding of Accelerated Approval is 6 months vs 10 months for standard after P3.
The Accelerated Approval I was reading and discussing is after P2 or anytime before primary endpoints are achieved and they finish the trial after approval and marketing (making money in P4 while providing confirmatory results to FDA to complete the trial). Yes they need to begin the trial to get both the surrogate and primary endpoint data, but maybe the TNBC delay is either CYDY fine tuning the surrogate endpoint data to better facilitate early approval based on FDA guidance or additional requested data?
The Accelerated Approval I was reading and discussing is after P2 or anytime before primary endpoints are achieved and they finish the trial after approval and marketing (making money in P4 while providing confirmatory results to FDA to complete the trial). Yes they need to begin the trial to get both the surrogate and primary endpoint data, but maybe the TNBC delay is either CYDY fine tuning the surrogate endpoint data to better facilitate early approval based on FDA guidance or additional requested data?
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