Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

I agree that B-OM will need some type of Phase 3 or 3/4, but the sachets are not the problem. There are many standard dessicants and other substances preventing caking that need no testing other than shelf life for packaging. These are not sachets for mixing oral delivery or injection; these are sachets for mixing a mouth wash as a topical treatment.

Whether or not the FDA assigns BTD to B-OM, it falls under an urgent, unmet need. There should be some rolling revue to approval with a phase 4 protocol written into the final study. Again, and can’t emphasize this enough, B-OM is a mouth wash that acts topically with very little systemic absorption.