As I said in my first line, "Brilacidin items of importance that are basic to know for those without medical training."
When I look at a trial that has not only completed a ph II, but, the company has talked about ways to bring it into ph III, I view that trial as ph III ready.
As I'm sure you'll have noticed, I didn't include the small ph II ovarian cancer study in my list of ph III ready drugs since it will need to be going into a larger ph IIa study.
The next steps for both ABSSSI and OM are ph III trials. I and others commonly view them as ph III ready at that point. And, I've even seen the company refer to them as ph III ready. I don't have links off hand, but, recall seeing it said by them.
Thanks for reading my post.
Message in reply to:
"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."
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