Torpy - excellent analysis, I tend to agree with you and your thoughts. Mate, it brings back a semblance of stats that I did back in first and second year uni some decades ago *blah*. Yes quite exciting that we should get a good representation of the 'population' as our sample increases.
Its very good to be conservative, don't forget the screening for 008 was and is presumably at least a bit more onerous compared to 002 and 003? The good thing here for us is that 002 and 003 will not involve effusion of the synovium thus be as subject to palcebo influence as 008 could've been? Still good to build in some fat when working with numbers going forward!
Chels - Good news here is that it is the primaries that we really do need to pass. There are examples of drugs that have failed their primary but attained good secondary results and went on to be commercially successful. However, again with some conservatism, I would think the authorities will indeed scrutinise us a fraction more as they know that once we are passed, we potentially will be prescribed to not just a few hundred thousands of patients...but many more in the future and for a broader set of indications.
It will of course depend on a lot of factors, how big is the market involved, what is the std of care, how effective is the std of care compared to our drug...is there a possibility of despite a drug not meeting its primary, a secondary is still lucrative and will help a good swathe of a given patient market or a subset of an indication for instance.
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