Saturday, December 16, 2017 1:14:09 PM
However, you need to understand it already had accelerated approval many years prior to that.
If you could glean anything from the full approval for Avastin, it might be trying to determine how the FDA sees the future, and prior to any form of approval for DCVax-L on nGBM, full approval for Avastin regarding rGBM was a logical first step. imho.
The hurry up was not for Avastin, imho, it was instead to set up a logical sea change for PFS as an approvable endpoint for GBM.
All this talk about imaging and psPD confoundment with PFS sort of hides the fact that 25% PFS blended occurred around 5 months before 30% OS blended for the DCVax-L phase III trial. Do you see? There could not have been a high amount of PFS psPD confoundment if people are already celebrating OS. imho. They just aren't that far apart.
I've done a couple rudimentary charts, and Boshie did some statistical analysis, but the point is, there should have been about 5% PFS (give or take) or less by about January 2017, imho, but instead there was 25% blended.
The price movement on NWBO started to react on December 6, 2017. That's a day after PFS became an approvable endpoint for GBM.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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