Innovation Pharmaceuticals Inc (IPIX)

[Empiricst1]

Interesting points you raise. I think that the 510 process, i.e. the swab as a medical device, can secure approval by being substantially the same as another, previously approved product. But the fact that it is applying an as yet unapproved medical product (Brilacidin) probably messes up any "easy" path. Spotts has a good insight into this process. I'd be interested in any other perspectives he might have. I just can't see how a patent on applying an unapproved product is much of a game changer. Still, need a successful FDA cycle, though that might not be hugely expensive for select nasal uses. Just speculating.