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Sunday, June 23, 2013 2:33:18 PM
As the OB reads today, at no other time has Icosapent Ethyl been approved, however, a citizen petition file by a Washington law firm is requesting to change Lovaza's OB to include the active ingrediate in Vascepa. This ruling should be out soon. In my opinion the FDA legal council is waiting for this ruling to determine Vascepa status.
It appears to me there's foul play, the motivation is to minimize the exsistance of Vascepa and it's active metabolites. The active metabolites of EPA are currently being targeted by numerous C-Path back organizations, either directly or through effiliations through C-Path board members.
-Pediatric orphan treatment for hypertriglycemia for one
-Resovins for dry eyes
....the list is long and runs through two Board members of C-Path. Both these board members either RUN or are very involved in private equity firms (Hedge Fund?).
It's been made crystal clear to Amarin to shut up and take it, hence the Anchor Ad Com.
I personally believe that Vascepa is almost impossible to value if you consider it a NCE and it's active metabolites.
I'm outing this so the FDA hopefully can make an ethical and correct decision. I expect them not to, though...the OIG will not be surprised.
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