What is FDA doing, why hasn’t BTD been granted y
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Posted On: 05/05/2025 9:07:19 AM
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What is FDA doing, why hasn’t BTD been granted yet or accelerated approval maybe? After ESMO will the FDA grant approval on something like this. If not BTD at a minimum.
Initially we only knew the median overall survival was 12+ months vs. Trodelvy's 11.8. Based on 5 patients surviving for 4 years with 4 cancer free they should give us BTD. But they may justify us not getting it because of the mix of data from various sources. If we can actually get media traction they'd probably change their tune.
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