Innovation Pharmaceuticals Inc (IPIX)

[williamssc]

Completely agree with BK's assesment.

Leo reported: We are developing Brilacidin under a Qualified Infectious Disease Product (QIDP) designation from the FDA as a potential new and unique treatment for ABSSSI.
Upon the FDA accepting our proposals, we will commence Phase 3 trials of Brilacidin for ABSSSI.

Following examples shows QIDP designation is good to have on your side in the approval process.

On May 23, FDA approved Dalvance (dalbavancin), an injectable drug, administered intravenously in two doses one week apart.

On June 20, FDA approved Sivextro (tedizolid phosphate), available for intravenous and oral use, administered once daily for six days.

On August 6, FDA approved Orbactiv (oritavancin), an injectable drug administered as a single dose to comprise a full course of therapy.

In these approvals, the drug’s manufacturer was able to take advantage of recently enacted incentives to help bring new antimicrobials to market. Each of these drugs was approved after being designated as a Qualified Infectious Disease Product (QIDP) under the GAIN Act. As part of this QIDP designation, FDA’s review of the drug application was expedited.