Biotech Values

[biomaven0]

head-to-head trial against Tasigna and/or Sprycel instead of trying to demonstrate superiority over Gleevec in the first line setting.

That makes no sense to me for two reasons:

Firstly, it's very hard to demonstrate any sort of superiority over Tasigna or Sprycel on efficacy in a first line setting - both work very well indeed. So it would have to be a non-inferiority trial, which doesn't buy you much from a marketing perspective.

Secondly, with Gleevec generics scheduled to arrive on the scene, it's important to get at least a foot in the door in front line, perhaps with high risk patients. Head-to-head with Gleevec is the way to do that.

There might also be a regulatory issue - Tasigna and Sprycel I think still have to do a confirmatory trial in front line and so I believe aren't eligible as the only comparator (but I'm not sure about this).

Peter