Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

Aawgghh, KarinCA. You had to tell me this! I was not, quite typically, at all aware of compassionate use. I had this nice little scenario already fixed in my mind.

1. IPIX files BTD application well in time. It contains roughly the same information as in their Jan and Aug 2018 corporate updates.
2. FDA rejects the application, but with guidance saying if IPIX will include certain information FDA might consider granting BTD.
3. IPIX looks around and, look, they do have it, but were just too ashamed to show it to FDA in the first try.
4. Modified BTD application gets filed sometime in August 2018.

Getting really speculative. I mean, the following is laying it really thick, but there are worse liars here around - so why not.

Term sheet was signed in August 2018. Potential suitor must have been aware of FDA's rejection and about requested additional information, took a look at IPIX additional data and concluded that IPIX probably has BTD at hand and decided to sign non-binding term sheet with IPIX.

What would the info that FDA was after be? How about this: Include patient level data for weekly cisplatin Per Protocol group. Kaplan Meier curve for it looks like the stuff below. Anybody can create it by deducting August Kaplan curves from January curves.




The really weird thing is the fact that the above Brilacidin curve still has hazard ratio edge, by Log-Rank, over Galera's GC4419, HR = 0.87 favoring Brilacidin. I guess you can now guess why I like this little scenario.

Have great weekend and do some biking :)