It is the $150m question Broderick. My understanding is the...

It is the $150m question Broderick.

My understanding is the first interim analysis is risk / benefit. With benefit derived from volume efficacy measures. So subjects in both groups.

Teva are committed to the trial up until this first interim analysis. And there is little doubt in my mind that the market is worried about this.

Trying to read the tea leaves around how the trial changes may interact with this Teva decision is far from straightforward. There is also the possibility that this first interim analysis has changed but the market has not been informed.

So the bear case is Teva walks and the trial continues (MSB funded). The second interim analysis is on efficacy from the new primary outcome.

Assuming positive second interim results these are then used to attract partnering for the second parallel trial. And this would explain the benefit of the change of primary outcomes in this trial to “match” those in the second trial.

Wrongly I had always assumed it was the second interim analysis that Teva were committed up to because this was a proper efficacy test. But this is not the case.

If an efficacy test has been moved forward (to this first interim analysis) to assist Teva make their decision then it would interesting to know what statistical penalty was extracted by the FDA. But on the other hand maybe Teva have already made their mind up.

But this is all far from simple; happy to be corrected on anything by those more knowledgeable.