You don’t need to do statistics if you have a dramatic treatment effect - when you see nearly half your patients get better after treatment even the dullest doctor knows something is going on. The doctors might not have been able to guess the exact response rate, but they would have known it wasn’t anything like the pilot study.
MSB’s CMO stated in one of the interim updates (from memory the 45%) that they were still seeing a 6o% death rate in the intubated ICU patients.
Actually it would be totally negligent for them to not monitor the blinded death rate given the predictive value of this data and the importance for their negotiation with Novartis. Imagine the negotiation value from being able to say the blinded death rate in the trial was 35% verses 60% in the patients outside the trial.
Novartis deal on the rocks, page-106
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