News Focus
News Focus
icon url

flipper44

08/05/19 11:55 AM

#238550 RE: survivor1x #238549

Not controlled enough. Just another escape hatch. What is so flipping hard about asking them them to provide the complete actual number of people actually alive (beating heartbeats) at three, four and five year time points from their phase III trial? The first two could be provided now, and the OS 5 number could be provided by December 28, 2019.

Is the FDA just going to let the scientific community at Novocure sell likely snake oil promises, or are we going to demand they tell the truth to patients about actual three, four and five year survival?

What in God’s name is the FDA doing?
icon url

longfellow95

08/05/19 12:17 PM

#238553 RE: survivor1x #238549

Since patients now use this device every month wouldn't they have real world figures?



Yes, Novocure would. But nobody else...
There were no post-approval requirements.
We will likely never know 'real world' effectiveness.

And Novocure don't let on about about average patient duration of treatment either, because of what could be construed from that.