voltnfan, LMAO!!!!!!!! That is priceless! I just choked on my Vascepa.
And next the FDA will say "they fumbled the ball" and "its on us" and grant us approval.
One bad dream, one good dream.
All, it wasnt me who penned this letter. On the top line I posted "From DeepBreath post 21592 from IHUB"
and there's MORE: from DeepBreath post 21592 from IHUB re Coleman:
Sent to the FDA via email
I am very concerned and troubled by Deputy Director Eric Coleman's position on PCSK9 drugs. Just recently this same Deputy Director led an ADCOM panel for Amarin's drug Vascepa for and extended label. Using the FDA's decision to rescind Amarin's SPA agreement after the ADCOM due to new medical science, I find it hard to believe that different standards are being held for different companies.
Further more, looking at the statement Director Coleman made regarding PCSK9 drugs, "These drugs will only have to meet existing standards for FDA clearance, including whether they cut cholesterol, lower blood pressure or inflammation ." Looking at the data presented at the OCT 16 ADCOM for Amarin's Vascepa, it clearly shows that with 4mg dosage, Vascepa cut's cholesterol and lowers inflammation markers.
I'm trying to understand the FDA's inconsistent standards with regards to these different drugs. According to the standards that Director Coleman is stating, Amarin, while already involved in a long term outcomes study, should be approved for the Anchor indication.
Please try to help me understand why an effective drug live Amarin's Vascepa, which does cut cholesterol and inflammation with the safety profile comparable to a placebo, has had it's SPA agreement rescinded when the Deputy Director himself agrees that drugs that produce these results will not need outcomes studies. I impatiently await your response.
So that's about 6200ish for 4 weeks now? Hugely disappointing. Thx again for keeping us up to speed, homebuilder.
As most longs have moved on to other sites for posting I only come here occassionaly now. Wow, LOL, what a zoo.
Saw all the posts responding to Ilovethe80's -- was good to see familiar names.
If I remember correctly, Lovaza was about 96K when we launched.
We're getting there but I still think we're gonna need some major dollars for advertising, public education & both Dr & public awareness of the huge benefits of Vascepa.
one blogger writing to another & neither cares if what he writes is the truth. Sure just make garbage up as you go along. ROFLOL You da bloggers!