Monday, September 30, 2019 5:15:16 PM
I'll admit, their presentation put me to sleep, so I cannot speak to every word, but I believe they've learned much from the failed trial, and the patients in the new trial will be better qualified to receive the maximum benefits. In the failed trial there are certainly a number of patients who're still alive who wouldn't have expected to be with the SOC, but that's not the acceptance criteria. It's sad, investigators can clearly see a certain group that benefits, yet the regulators can't see it being definitive enough to approve the drug with a limited label.
Gary
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