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Thursday, April 14, 2022 6:51:10 PM
BBI,
https://www.clinicaltrials.gov/ct2/show/NCT02719327?term=Vascepa&draw=2&rank=9
The BRAVE study should read out with positive results. Prior studies have shown that Icosapent ethyl had statistically significant effects on both the primary and secondary endpoints in BRAVE. This study is fairly invasive. Each patient will need to undergo 3 separate spinal taps.(unless there is another way to collect CSF.) The study also has a data monitoring committee. I would think that the committee would have halted the study if the data collected, to this point, wasn't positive. I don't know if this study would be enough to apply for an SNDA. FDA did recently lower the bar for Alzheimer's disease approvals.
Sleven,
https://www.clinicaltrials.gov/ct2/show/NCT02719327?term=Vascepa&draw=2&rank=9
The BRAVE study should read out with positive results. Prior studies have shown that Icosapent ethyl had statistically significant effects on both the primary and secondary endpoints in BRAVE. This study is fairly invasive. Each patient will need to undergo 3 separate spinal taps.(unless there is another way to collect CSF.) The study also has a data monitoring committee. I would think that the committee would have halted the study if the data collected, to this point, wasn't positive. I don't know if this study would be enough to apply for an SNDA. FDA did recently lower the bar for Alzheimer's disease approvals.
Sleven,
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