Innovation Pharmaceuticals Inc (IPIX)

[MinnieM]

With the low absorption rate in Brilacidin OM swish and spit vs Brilacidin ABSSSI dosing being IV it would be surprising for safety to be a major issue with the FDA for the OM trial. But, they may indeed want a larger ph 3 trial. My guess is lack of funds is more likely to be a hold up. We need a partner/buyout now.






In Reply to 'noretreat'
FDA ignored the lower dosage in the ABSSSI trial and will likely require large samples again in the proposed OM trial. It is just how they operate...prior safety issues must be addressed.

I get what you are saying, but the FDA will need proof nevertheless.

My guess is that this is why there has been no comment from IPIX about the B-OM P3 design.