Thursday, March 08, 2018 3:19:55 PM
Besides. Unless there was a mid-trial trial manufacturing (aka: efficacy) improvement, imo, there are likely no more original placebo patients left to PFS event, and likely only six (give or take) original placebo patients alive (regardless if they crossed over or not.) How on earth could unblinding have any impact on trial integrity under such circumstances at this late stage in the trial? Remember me....I'm the one that went on for years about preserving trial integrity. They can still collect data after unblinding.
On the other hand, if there was mid-trial improvement, hopefully the single arm whole trial analysis will capture its impact in a front to back style analysis. It might actually be more dramatic if this occurred.
JMHO.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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