Replies to post #110425 on Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

Just to better clarify, the QIDP and it's fast-track are already in place for Brilacidin-ABSSSI and Phase 3 is also already a slam dunk. What is in question are the elements of QIDP fast-rack that will be applied. At least one and possibly up to all of the following are possible and will result from the FDA Phase 2 meeting.

Accelerated review only. (Reduces the review time between trials from > 10 months to ~ 6 months)
Rolling review
Surrogate endpoints
FDA intensive guidance and organizational commitment
60 day FDA responses

The trifecta: rolling review with surrogate endpoints, intensive guidance and organizational commitment, 60 day BLA and NDA guaranteed response time.

Also, some of the elements depend on a sponsors ability to guarantee rapid marketing and product quality after approval. In CTIX's case that will require a partner or license.

As we wait on the FDA outcome we can be very optimistic that FDA phase3 approval will happen with QIDP designation. Just review ECCMID 2015 slides 19-21 and be assured. Brilacidin was found safe and effective in two phase 2 studies. This is my opinion with evidence.