Dew,
That does beg the question as to whether or not SGP shares your assessment that Respond-2 will probably not be sufficient, and if so, why run a trial that they deem likely to be insufficient?
I suppose they may consider a smaller Phase 3, run more like a Phase 2 to be more economical than running a full fledged Phase 3, as they feel they need more investigation before committing such resources. But I don't buy that one.
Perhaps they feel that the cost of running it, and maintaining the indication will be more than paid off by increased share price.
Who knows what reason they may have. It just does not seem sound practice for Schering to run a Phase 3 that they deem likely insufficient to gain a label expansion or registration on.
So that is where my presumption comes in. There may be legitimate reasons why the presumption that SGP is running a trial they expect to use for registration may not be accurate however. That would derail my comparison with Prove 3, as then the FDA could remain consistent by then requiring SGP to run a second, but larger Phase 3 down the road.
Tinker
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