Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

DaubersUP, your example manages to demonstrate two important things at the same time.

1. Significance of early BTD to companies working with substitute endpoints. In this case it is known that Hepatic venous pressure gradient (HVPG) does correlate with the stage of liver fibrosis. What is obviously not well known is what change in HVPG does constitute reliable indication of clinically meaningful change in NASH fibrosis. At least that seems to be FDA's view. Therefore, Galectin would have benefitted from applying for BTD as soon as possible i.e. before the start of p2 trial - they might have even managed to soften up FDA's requirements for meaningful change in HVPG with closer contact during the design of p2 trial.

2. Good example of what FDA requires for approval of BTD - reasonable clarity is good way of putting it.