Replies to post #247375 on Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

http://investor.galectintherapeutics.com/news-releases/news-release-details/galectin-therapeutics-proceeds-phase-3-development-gr-md-02-nash
If you're short on time skip to paragraph 4.

[Amatuer17]

Here is very similar case

NASH-CX - no other drug has shown any results - this was 1st in class drug. Co applied for BTD, set End of P2 meeting.
BTD was rejected, co is going ahead with P3 based FDA inputs and guidance

Galectin Therapeutics Proceeds to Phase 3 Development of GR-MD-02 for NASH Cirrhosis Following FDA Meeting $GALT

https://seekingalpha.com/pr/17162133

[frrol]

I am not familiar with any. There's nothing out there in the public domain about BTD denials for several reasons.

But oral mucositus is "ripe" for BTD. SOM needs BTD therapies and the FDA just granted it for Galera's drug. I did some DD on Galera and could not tell when they applied for BTD, just when it was granted (Feb of this year). Their trial was quite big, 223 patients (ours was 61).

Our B-OM had strong results in one arm; the other arm was bad (performed 'worse' than placebo). So we'll see what the FDA makes of our application. We likely filed a preliminary BTDRA (which is relatively new) and clearly got the nod to apply, so we've got a good shot. The good arm showed that we've likely got an effective therapy. The FDA no doubt has notes about how they'd like us to proceed with Phase 3, and we'll get them mid December according to Leo.