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Re: ShawnP123 post# 6883

Wednesday, 03/22/2017 11:49:48 PM

Wednesday, March 22, 2017 11:49:48 PM

Post# of 20617
I reached out to IR again and asked about the status of European approval. Again, the answer makes sense and shows everyone how important it is to contact the official places first before starting to spin conspiracy theories.

My question was:

Innovus requested regulatory guidance for filing Fluticare in Europe and the UK's MHRA was chosen as a Reference Member State in Europe. What's the status here? It was mentioned a response would be expected in 3-4 months from the MHRA. These have long passed. Has Innovus ever heard anything back from the MHRA?



IR answer:


Due to Brexit occurring shortly after the guidance filing, Europe will no longer recognize the UK's Reference Member State Status. The company is seeking another European country in which to do the trials and is close to a resolution.



This makes sense even though I'm surprised that UK's reference member state status isn't recognized anymore already now, because UK is still a member of the EU and will remain so until exit negotiations have finished sometime in early 2019. Anyway, we now have an answer that is credible.

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