Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

You may be correct, but that would be a first. All in all, I think your post is just more conjecture. A previous post stated a CTO as fact while in this one it is more speculative. Just the same, I'm looking for a Brilacidin deal before end of summer as the Phase 3 should have started by then. I suspect negotiations will happen as soon as the FDA issues the parameters of the QIDP.

Once that happens, a true valuation can be placed on the late stage developmental drug. QIDP designation advantages:

Fast-track

* expedited review
* rolling review

Breakthrough Therapy

* intensive guidance for development
* organizational commitment-involvement of FDA senior managers, cross-discipline project lead for review, regulatory project manager assigned.
* rolling review-regulatory project manager may recommend advanced review ahead of NDA review.

Accelerated approval

All of the above plus "Approval based on an effect on a surrogate
endpoint or an intermediate clinical endpoint that is reasonably
likely to predict a drug’s clinical benefit."

Any one of the above adds to the value of a pre-FDA approval license, and all of the above (The Trifecta) will easily put B-ABSSSI above $1 billion in upfront and milestone payments.

Reference: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf