Innovation Pharmaceuticals Inc (IPIX)

[KMBJN]

market yawns at small samples and substantial drop outs

What substantial dropouts?

Brilacidin group had 21 in ITT, and 19 PP - so perhaps 2 dropouts there (9.5%).

Placebo group had 25 in ITT, and 20 in PP - so perhaps 5 dropouts there (20%).

The remaining folks did not get enough radiation to be included in primary endpoint. They needed to have 55 Gray (cumulative). Some people can't tolerate the radiation burns, the pain, the sores, the dry mouth, etc... or maybe their cancer got worse and they went to hospice (since the treatment is so difficult), so they cut their treatment short.

Only 46 of the 61 finished the full radiation plan, which perhaps you are calling a 24.5% dropout high?

This isn't that unusual. One study showed 30% of Medicare patients were unable to complete their radiation treatment after surgery, and only 50% before surgery.

http://www.auntminnie.com/index.aspx?sec=ser&sub=def&pag=dis&ItemID=87365


Taken together then, I supposed only 41 of the 61 achieved the final radiation plan and stayed on study protocol (36.1%). I guess that is kind of high, but most of it was because of radiation dosing. I wonder how many dropped out (not PP) overall, and why.

The "market" and traders may be yawning, but as others have noted, any improvement / prevention of severe OM is very meaningful for patients going through this very difficult and painful treatment and disease.

If it helps patients, it will be a winner in the marketplace of effective and safe medical treatments. I'm looking forward to the QOL, pain, and AUC of mucositis-time endpoints (the best measure, IMO, with special weighting given to more severe scores since those events are so much worse on QOL and outcomes).