Novartis deal on the rocks, page-23

"You lot do realise that the limited amount of information released yesterday points to a reduction
in mortality of some were between 30 and 40 odd %."

can you please elaborate more on this?

"Indeed if the required survival benefit was set at a level more in line with the USA emergency use criteria we would have been stopped at 30% enrollment for overwhelming efficacy."

What is the benefit level set for EU criteria?

"The DSMB has recommended that this trial stop, not because the results show a poor survival benefit but because the trial design prevents the projections from meeting thire primary end point."

Yes I can see that could be theq the case. But is there an argument for the trail being continued to full enrollment to obtain a complete data set of secondary endpoints?


being stopped early the results will be criticized heavily won't they?

I may have missed some discussion yesterday however a point that has not been widely discussed and should be.HAS THE DSMB STOPPED THE TRIAL TO FAST TRACK EMERGENCY USE?

YES. If not that could be the final outcome.

WHY

In normal times the DSMC would have recommended a alteration to the enrollment to address the issues that they have seen develope over time. This could have been as easy as including none ventilated patients on high flow oxygen.

They did not make this recommendation because the data is sufficient for EU and that is what the US government funding was to be used for and the US is in desperate need of a therapy that works.

Now tell me why Novartis would want to dump the deal?

I understand the theory. I hope its valid.