Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

"A little bit confused by this: "

Sorry, I was not very clear. Soligenix trial accepts subjects only on cisplatin Q3W schedule. 80 - 100 mg/m^2 in Soligenix filing is shorthand for 80 to 100 mg/m^2 once every 3 weeks. Both Galera and IPIX got approval for both cisplatin schedules Q3W and Q1W (30 to 40 mg/m^2 weekly). Jabbering about doses in Galera's P2 is about total number of doses needed for 6 to 7 weeks of radiation treatment.

Of course, FDA's approval does not mean that IPIX will elect to run a trial with both cisplatin schedules. I would go for more certain approval - trial with cisplatin Q3W schedule subjects only and worry getting approval for Q1W schedule later. Soligenix would not be running it's trial as it is unless FDA has approved including only subjects on Q3W cisplatin schedule.

Before IPIX is allowed to start P3 with brilacidin sachets they need to show to FDA that brilacidin powder is easily and evenly mixed into water. I don't see much difference between patients taking home ready mixed rinses in closed measuring cups or taking bunch of sachets, a measuring cup plus instructions how to mix the rinse.