Innovation Pharmaceuticals Inc (IPIX)

[Chronic]

Galera Therapeutics Receives FDA Breakthrough Therapy Designation for GC4419 for the Reduction of Severe Oral Mucositis
Designation Based on Positive Results of Phase 2b Trial of GC4419

Severe Oral Mucositis Affects 70 Percent of Head & Neck Cancer Patients Receiving Radiotherapy

February 28, 2018

---------------

Galera's phase 2b results were announced a week after Brilacidin yet GC4419 received BTD. If IPIX was going to receive BTD they would have already by now. Perhaps the FDA looked at the entire "intent-to-treat" data of the Brilacidin trial and was less than impressed. Us investors don't know because the data for 25% of the trial participants was never publicly released.

"Of the 61 patients randomized, 46 patients met the cumulative radiation dose criteria of at least 55 Gy..."

There are 15 patients who didn't receive at least 55Gy radiation. So IPIX cut them out of the results. However, did any of these patients develop severe OM? What bucket were they in? Why did they not receive 55 Gy radiation?

Stock is down nearly 50% since the release of OM top line data. Obviously investors are concerned.