Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

TIAB, but of course FDA will request an efficacy analysis covering certain subsets. I guarantee that at least this subset analysis will be required:

Efficacy with different cisplatin schedules: There is some evidence that most toxicities, including oral mucositis, are more severe with weekly cisplatin and there is compelling evidence that cisplatin every 3 weeks is more effective in treating HNC. Differences in treatment effectiveness of SOM in these groups is of great interest to FDA and, for god shakes TIAB, to ANY treating doctor.

Applicant also needs to address efficacy in subjects with HPV induced HNC vs subjects without HPV. HPV induced HNC is considered easier to treat and that may alter efficacy results in treatment of SOM.