AFR - 10 Aril 2017, page-9

Lol yes Aatisket you know it is completely made up for a few reasons.

First, and most obviously, the primary outcome is not time to event. Its recurrent HF-MACE. So its got nothing to with half of any patients for a year. And the hint for the complexity here was in the “joint frailty model” that is being used.

On the positive … the more times a trial passes an interim futility test the better the chances of final success.

The second positive is it is wrong to automatically assume the interim futility test is purely a statistical exercise.

Sometimes there are pre-specified boundaries which are set in concrete. But other times there is flexibility; and there are scenarios where scientifically it is important to continue to the bitter end to get a decisive result. In other words over-rule the interim futility boundary.

But here MSB are indicating – two steps. It passed the interim and the DMC recommend continuing. This is stronger than MSB simply informing us that the DMC recommended continuing.

On the downside goodness knows where the boundaries were actually set. And MSB seem a little coy in coming forward about when the parallel 600 patient trial will start as agreed with the FDA.