Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

The 10-K says:
"Other FDA programs intended to expedite development and review include accelerated approval, which allows the FDA to approve a drug on the basis of a surrogate endpoint that is reasonably likely to predict clinical benefit, and Breakthrough Therapy designation, which is intended to expedite the development and review of drugs for serious or life-threatening conditions and where preliminary clinical evidence shows that the drug may have substantial improvement on at least one clinically significant endpoint over available therapy."

The FDA says:
"Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

To determine whether the improvement over available therapy is substantial is a matter of judgment and depends on both the magnitude of the treatment effect, which could include duration of the effect, and the importance of the observed clinical outcome. In general, the preliminary clinical evidence should show a clear advantage over available therapy.

For purposes of Breakthrough Therapy designation, clinically significant endpoint generally refers to an endpoint that measures an effect on irreversible morbidity or mortality (IMM) or on symptoms that represent serious consequences of the disease. A clinically significant endpoint can also refer to findings that suggest an effect on IMM or serious symptoms, including:

An effect on an established surrogate endpoint
An effect on a surrogate endpoint or intermediate clinical endpoint considered reasonably likely to predict a clinical benefit (i.e., the accelerated approval standard)
An effect on a pharmacodynamic biomarker(s) that does not meet criteria for an acceptable surrogate endpoint, but strongly suggests the potential for a clinically meaningful effect on the underlying disease
A significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity for an oncology agent), with evidence of similar efficacy"
https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm


The FDA doesn't seem to take method of delivery into consideration for BTD purposes...at least not in the above description. So the benefits of swish and spit versus 1hr infusion prior to each treatment that may exist in the marketplace and in practice don't seem to matter for this purpose.

But it doesn't seem to matter whether B-OM provides an improvement over Galera's GC4419 in "an effect on an established surrogate endpoint" or "a significantly improved safety profile" because at this point GC4419 doesn't meet the definition of "available therapy"....it isn't an approved drug.

So that comparison doesn't even need to be done in the FDA's determination regarding B-OM. It seems to me that the submission only had to establish that B-OM is more effective than the current treatment (I've read that there is none) and that it is safe. Is there any reason to think that the FDA might feel that the P2 trial didn't do that?