Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

I don't think so. My understanding of this sachet business is that the change boils down to putting the same powder used in P2 trial to mix the rinse into pre-measured sachets. That eliminates one step from the process - measuring the correct amount of powder for mixing. But I may be wrong - I never bothered to look closely how B was administered in P2.

If you are looking for reasons why FDA might have rejected the initial BTD application and we are now in refiled stage: maybe FDA wanted to have more info about systemic exposure to Brilacidin in P2 SOM trial. Just a badly educated guess, based on Brilacidin history in ABSSSI.