Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

LilKahuna, I agree that a drug with BTD is more likely than the one without to manage with one phase 2 trial and even be approved based on single phase 3 trial. But I don't see these advantages being provided by BTD per se. They are more like consequences of proven benefits that were anticipated but not promised by BTD designation. FDA is very careful in its wording about BTD benefits concerning clinical trials:

These trial designs may result in smaller trials or more efficient trials that require less time to complete and may help minimize the number of patients exposed to a potentially less efficacious treatment

Doesn't mean that a company can't use assigned BTD as a 'proof' of FDA's belief on potential efficacy of their drug (FDA does think so) and even as evidence for potentially rapid commercialization (if all pans out as anticipated, FDA will oblige).