Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"Brilacidin for ABSSSI is ph3 ready. Ph2 was dosed via IV in hundreds of patients.
Brilacidin for OM is ph3 ready. Ph2 was dosed via swish and spit."

Is "finished Phase 2" your operating Phase 3 definition?
The Company published a Table in the latest 10Q that described B-ABSSSI as "Phase 2(completed)" and B-OM as "Phase 2 Study (completed) Phase 3 in preparation".

"Ph3 ready" doesn't seem to be a phrase that the Company itself uses. It isn't in the latest 10-Q or 10-K, leaving me to wonder whether the FDA may not like the phrase or agree with its use under these circumstances. Or I suppose the Company just might not be as comfortable with it as you seem to be. It does SOUND meaningful.

The specifics per the 10-Q:
Re B-ABSSSI:
The Company submitted a Special Protocol Assessment (SPA) request including a proposed study design to the FDA in 2016. It then "received from the FDA comments and considerations for incorporation into our study design".
The Company never responded to the FDA comments.

Re B-OM:
Per the 10-Q the Company and the U.S. Food and Drug Administration (FDA) have completed an End-of-Phase 2 meeting (in December of 2018) concerning the continuing development of Brilacidin oral rinse to decrease the incidence of severe OM in HNC patients receiving chemoradiation. Both parties agreed to an acceptable Brilacidin Phase 3 development pathway, including studying Brilacidin oral rinse effects on severe OM when cisplatin, the preferred chemotherapy regimen in HNC care, is administered in higher concentrations (80-100 mg/m2) every 21 days, and at lower concentrations (30-40 mg/m2) administered weekly as part of the chemoradiation regimen.
The phrase "oral mucositis" appears a total of three(3) times in the latest 10-Q. The About Innovation Pharmaceuticals section of the latest press release says:
"A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources."