Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

And in today's PR:
"The meeting with IPIX Pharma has been scheduled by EMA for mid-April 2019 and will serve to complement the regulatory feedback and advice obtained by the Company from the already completed End-of-Phase 2 Meeting held with the U.S. Food and Drug Administration (FDA). At this meeting, an acceptable Phase 3 development pathway was agreed upon by the FDA and the Company to advance Brilacidin for the prevention of SOM in HNC."

The following has been said before, but please masticate it one more time.
Only one drug has been approved for oral mucositis and that approval is for very different indication (in patients with hematologic malignancies receiving myelotoxic therapy) than targeted by Brilacidin, GC4419 and Dusquetide.

In this kind of situation, where there is no previous regulatory specifications available it makes sense to go and ask those agencies what would satisfy them. And EMA may be crucial if, as it seems, there will be some 'competition' of USA subjects for trials - both Galera and Soligenix are in phase 3. Next comer may need to cast its net also outside USA a.k.a. Europe. If my memory serves me right running even a part of a trial in Europe requires EMA's approval.

BTW No 1: Dusquetide P3 trial is registered with EMA under Soligenix UK Limited. Probably just an end run around FDA regulations. What else? [IRONY, in case ...]
EMA:
https://www.clinicaltrialsregister.eu/ctr-search/search?query=Soligenix

Soligenix UK Limited
https://suite.endole.co.uk/insight/company/06560847-soligenix-uk-limited

The last one looks familiar, somehow.

BTW No 2: I guess Soligenix Inc is a bit miffed with Brexit. Subsidiary taking off from British Isles might be on the books. I wonder if current UK director plus obligatory executive assistant will make it.