Innovation Pharmaceuticals Inc (IPIX)

[DaubersUP]

As LR posted.....here is something we will see in the PR after the EOP2 meeting. "IF" we have failed to capture BTD, Leo will tell us why just like they did here:

“While the company believes the results of the Phase 2 NASH-CX trial may represent a breakthrough for patients with NASH cirrhosis and believes that the results meet the FDA requirements for Breakthrough Therapy designation, the FDA has not granted breakthrough designation at this time based on the Agency’s current assessment that additional confirmatory data are needed to identify the level of change in HVPG that is reasonably likely to predict clinical outcomes. Although we disagree with FDA’s decision not to grant Breakthrough Therapy designation at this time, we understand their position because our NASH-CX trial is to our knowledge indeed the first randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in HVPG in NASH cirrhosis patients. Importantly, the Phase 3 program will not be impeded by the lack of Breakthrough Designation at this time. The program continues to benefit from Fast Track designation which provides many of the same advantages as Breakthrough Therapy designation, including potential for accelerated approval and priority review.”

http://investor.galectintherapeutics.com/news-releases/news-release-details/galectin-therapeutics-proceeds-phase-3-development-gr-md-02-nash