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Posted On: 02/08/2019 4:38:32 PM
Post# of 72441
This seems to verify that they are going for approval under the easier European standards first.
As I've said before, it's possible that Bril-OM might be considered a "medical device" under European guidelines, as it is not ingested but is a "topical" treatment for the oral membranes. Medical devices are a lot easier to get approved.
Quote:
Subsequent to the balance sheet date, the Company is establishing a wholly-owned European subsidiary for the purpose of the development of its drug candidates internationally. The subsidiary will serve as a key hub for strategic collaboration with European companies and medical communities in addition to providing cost-saving efficiencies and flexibility with respect to developing Brilacidin under European Medicines Agency standards.
As I've said before, it's possible that Bril-OM might be considered a "medical device" under European guidelines, as it is not ingested but is a "topical" treatment for the oral membranes. Medical devices are a lot easier to get approved.
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