Replies to post #244972 on Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

Pardon my ignorance, but can we back up a few steps? I know you know these things but I need the review.

You said "How can a sponsor file a BTD before data is in and fully analyzed?"

In a May 9th PR the Company said that it had "concluded its review of all data outputs and corresponding analyses from its successfully completed Phase 2 Brilacidin-OM trial (see NCT02324335) for the indication of decreasing the incidence of Severe Oral Mucositis (Severe OM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving chemoradiation."

On 6/28 the Company signed an agreement that would provide financing contingent upon "the granting by the U.S. Food and Drug Administration of the Company’s request for Breakthrough Therapy Designation for the Company’s Brilacidin compound in the indication of Oral Mucositis."

On 9/20 the Company filed a PR saying "A Breakthrough Therapy Designation application is currently under review with the FDA."

This afternoon you asked "How can a sponsor file a BTD before data is in and fully analyzed?"

In response I provided the complete section of the FDA's "Qualifying Criteria for Breakthrough Therapy Designation", highlighting what I thought was the relevant language.

Your response to that post was the post that I'm responding to now.

The sentence that preceded the one that I highlighted read as follows:
"For purposes of breakthrough therapy designation, preliminary clinical evidence
means evidence that is sufficient to indicate that the drug may demonstrate substantial
improvement in effectiveness or safety over available therapies, but in most cases is not
sufficient to establish safety and effectiveness for purposes of approval."
It's my understanding that there is no approved drug available for OM treatment. It would seem that showing improvement over that would be fairly simple. Wouldn't the results from the "successfully completed Phase 2 Brilacidin-OM trial" have satisfied that?

What event triggered the Company's ability to file the application that was under FDA review on 9/20 if not the conclusion of the "review of all data outputs and corresponding analyses" announced on May 9th?