Biotech Values

[gofishmarko]

>> In that respect, I do think he is being consistent. <<

He may be consistent , but I still maintain that he , and the FDA , are illogical.

Knowing that I'm beating a dead horse :

An oncology drug that achieves absolutely spectacular statistical significance on a surrogate endpoint has no better chance of demonstrating any true clinical benefit than does a drug like Provenge , and probably DN-101 also , that has already shown an effect on the ultimate clinical benefit , survival.

The marginal statistical packages for survival of Provenge and DN-101 are as good or better than the best statistical package for any current oncology surrogate , because with all of the surrogates there is only a " reasonable likelyhood " that they will , in fact , predict a clinical benefit.

If there is a split occuring between CDER and CBER , I suspect it's over just this issue , and my vote would go with CBER , and logic.