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Message: The European Medicines Agency (EMA)... furthermore...
Thanks Kelsee for a valuable post.
From your post "The centralized procedure is compulsory for: human medicines for the treatment of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS), cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases;"
This might imply that since the rvx-208 trial will target diabetes mellitus patients with CVD that it requires central approval and that seems like good news from a market efficiency and profile perspective.
Also, the fact that approvals take 210 days and more for approval and the fact that RVX has achieved at least 1 level of approval suggests that RVX started working with the European agencies at least in November of 2014.
We (the market) does require further detail and clarification on what type of trial approval was achieved and is the path now clear for BETonMACE trials. It sounds like more approvals are required but it also sounds like a done deal.
Well, IMHO the rvx-208 good news and votes of confidence continue to happen at faster rates.
At the conference in Sweden from June 27th to 30th RVX will be able to continue networking and this time they will be doing their discussions with phase lll BETonMACE approval in their arsenal. That will dramatically enhance credibility and relevance.
Add to the the closing of the Hepalink deal and everything is moving together extremely well.
GLTA
Toinv :)
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