Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

A breakthrough therapy is a drug:
-intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
-preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/fdasia/ucm329491.htm

What we learned from the Galera grant is that OM meets the "serious or life threatening disease or condition" standard.

If the IPIX submission falls short its due to something the FDA doesn't like about the preliminary clinical evidence qualifications.