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Re: A deleted message

Sunday, 03/06/2016 10:46:34 PM

Sunday, March 06, 2016 10:46:34 PM

Post# of 347009

Ending the trial because bavi didn't work would be futility. Having it work according to plan but having an outlying control arm simply makes continuing less valuable


"Working" in a controlled P3 trial is having the treatment arm perform sufficiently better than the control arm.

When that does not happen, the trial has failed.

When they decide early that failure is the highly probable result, the trial may be halted for futility. And that is what happened here. This message is clear and unambiguous.

"Valuable" data from this trial would have been something to submit a BLA on to get the drug to market. With this result, there is certainly no BLA. And likely no further progress in any Bavi+chemo. So yes, a bit less valuable.

This concept that the Bavi arm performed as expected so all is good is complete garbage. Say you enter a horse in a race and have high hopes for it winning. Race is over, and it runs the time you expected, but comes in last. Do you get excited when your horse ran "as expected"? Was it just bad luck? Were the other horses using some new ilegal drug? Does not matter.

One can hope for the Bavi story playing out better in the IO combo space, but spinning this trial as anything other than a failure is wrong.
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