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Disagree Amarin should have listed Trigs...period. 200-500 for the reduction of Trigs. an analysis of recent CV outcomes studies show that lowering Trig by 45 points Reduces CV events by 1.8% per 45 mg/dl reduction.
We feel the reduction is significant to expand our label to treat this population while awaiting our REDUCEIT outcomes study.
In the population we purpose this would translate into a 720,000 potential reduction in CV events potentially saving Billions of health care related costs.
It sounded like REDUCEIT wording to me also. Very big mistake.
The FDA has created a real problem by not communicating to Amarin and the SEC that the stock should be haulted until PDFUA. For those that sold I'm sorry. The FDA has no choice but to approve. They have no out that doesn't include huge Legislative and legal ramifications.
I hope the company is talking to panel members, they need to reach out and thank them.
The FDA has created a real problem by not communicating to Amarin and the SEC that the stock should be haulted until PDFUA. For those that sold I'm sorry. The FDA has no choice but to approve. They have no out that doesn't include huge Legislative and legal ramifications.
I hope the company is talking to panel members, they need to reach out and thank them.
JL
The Non FDA panel did a great job. At the end most new the FDA was looking for them to vote No and site safety. It didn't happen. The Chair voted yes and praised the safety. FDA guidance does not provide room for the FDA to break contract without public safety concern. Unless the FDA would like to pull all O3's off the market.
Amarin has another option that is better than sueing, I hope they take me up on it.
Williams
$This is what happened at the Ad Com$
First the non FDA committee members did an amazing job, all of them. Not all realized they where used while in session, but most figured the game by the end. Thank You
The FDA created safety talking points to provide cover for a CRL and breaking the SPA.
1) Increase blood sugars
2) Bleeding
3) HDL bump
Non FDA panel members where fed talking points some how, whether the source is traceable will be determined. Dr. Hiatt was the first to recognized he was being played. Requesting statistics for both blood sugars and head bleeds. (Both head bleed where either due to trauma or an AV malformation/ruptured blood vessel. Nothing to do with Vascepa).
The FDA never planned to approve Vascepa, they feel this should be a big pharm indication, that was also clear.
Panel member exposed the witch hunt in the second half. Dr Hiatt questioned the FDA on SPA agreement, safety, early indications of REDUCEIT factors, and he was eventually told to stop with the "what-if" questions. The FDA steered one panel member away from HDL discussion. She later used it as the reason for her "NO".
When Amarin starts to trade this AM the FDA panel members and those that conspired become Security Criminals.
Please let the Panel members be, they did a great job in exposing the game.
Please let the FDA play this out, they have only one way out let them through the door.
Please leave Amarin to conduct their business, they're in over their heads but now recognize what's playing out.
Good Luck Shorts and Longs this was/is a great game.
I will remain long until PDUFA.
Williams
For once I agree. It be nice if the FDA at least took us to a movie before intercourse.
Start printing those AACE guidelines out in pocket size, strap a big Amarin logo on the back and sell!
Cancel REDUCEIT, get a partner AZN (needs us now as much as we need them) and let's go.
Your wrong, Amarin isn't the NIH, it's a business. All Phama big and small are on notice. The FDA is willing to not abide by SPA 's within their current guidelines. Today we witness the end of Pharma innovation. Without an outcomes $250 million dollar study your met all endpoints safer than placebo SPA drug will not be approved. The Chair voted, yes, I implore you read his safety comment. All Pharma lost today, not just Amarin.
Amarin sales reps to start handing out new AACE lipid guidelines with AACE position statement. This is about treating patients, not ego's that should be fired at the FDA.
I repeat, the FDA can't break SPA. The have no guidance or cover. Coleman admitted safety, Marine Approved, AACE guidelines call for treatment. The FDA has embarrassed themselves today. Ad Com members where ashamed to be part of such a scandal. No Anchor approval will likely prove to not treat and contribute to deaths.
Amarin cash $270 million
2014 RI $40 million
2015 RI $40
2016 RI $30
2017 RI $30
2018 maybe if the placebo didn't overestimate results and the FDA lives up to the SPA.
There's nothing to say the FDA will ever hold a SPA...Committee tried to warn them, but they where set on taking Amarin down. All small Bio's should CP the FDA, or they can all close shop.
The FDA only deals with BP.
Cancel REDUCEIT tomorrow and double sales force with looser sales guidelines using new AACE guidelines,
Adam knew the FDA wanted to pull the SPA agreement.
The committee requested the voting question be changed, the FDA refused. The panel wasn't going to read the tea leaves. The FDA rushed the request to even discuss changing the question...it's all there for the World to view.
Not in light of the AACE guidelines, which are likely the new ATP4 guidelines. It would be a health concern if the FDA assumes they are better suited than clinical endocrinologist to make that judgement.
If BP was driving this ship the FDA wouldn't dare!
THE FDA CAN'T BREAK THE ANCHOR SPA
The committee went on record to state it met SPA safety and efficasy. The FDA requested the comittee go on record and read the tea leaves of REDUCEIT. SPA agreement per FDA can only be broken for safety reasons.
"Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident."
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
The only "public health concerns" I see, are if the FDA doesn't follow the Lipid guidelines of AACE. They have expressivly added Trigs should be considered a CHD risk factor. Agressive treatment at levels of 150. It was poor science not to have this represented better. The document is here:
https://www.aace.com/publications/algorithm
In both the consensus statement and Diabetic treatment guidelines is specifically recommends agressive treatment for dyslipdemia and CAD type 2 DM. This treatment includes Omega 3 EE, and in the statement it guarded against DHA containg Omega 3's.
The FDA would be very unwise to change the bar because of failed studies that include a completely separate drug.
The committee went on record to state it met SPA safety and efficasy. The FDA requested the comittee go on record and read the tea leaves of REDUCEIT. SPA agreement per FDA can only be broken for safety reasons.
"Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident."
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
The only "public health concerns" I see, are if the FDA doesn't follow the Lipid guidelines of AACE. They have expressivly added Trigs should be considered a CHD risk factor. Agressive treatment at levels of 150. It was poor science not to have this represented better. The document is here:
https://www.aace.com/publications/algorithm
In both the consensus statement and Diabetic treatment guidelines is specifically recommends agressive treatment for dyslipdemia and CAD type 2 DM. This treatment includes Omega 3 EE, and in the statement it guarded against DHA containg Omega 3's.
The FDA would be very unwise to change the bar because of failed studies that include a completely separate drug.
FDA breaks SPA, note to all BIO. The FDA clearly loaded a question that can't be answered.
I vote that we announce, dropping REDUCEIT, and sell Vascepa off label.
This panel thinks the FDA is stupid.
They are changing the question now!
As an investor I do not support REDUCIT costs without Anchor. End of Story.
I like Dr. Hiatt now!
Hiatt..... Is a complete d-bag!
Hyatt is a no... You think?
These public speakers are incredible! Keep them coming!
It sounds like you are prescribing a beer?
Knowing his involvement with Inflamation study I would hope he would lean toward the Eicosanoid system and Vascepa....that what his study drug targets. Obviously a big conflict of interest that wasn't disclosed.
I'm giving him a yes.
I might have a heart attack before the vote! Who"s gonna mention the new Clinical Endocrine 2013 lipid guidelines? This better come out at some point!
No inflammatory or ecosanoid mentioned yet which is a true shame. Dr. Everett is running a phase 3 inflammatory trial with an arthritis/cancer drug...which he should have disclosed but didn't.
No inflammatory or ecosanoid mentioned yet which is a true shame. Dr. Everett is running a phase 3 inflammatory trial with an arthritis/cancer drug...which he should have disclosed but didn't.
One thing I hope Amarin picks up on! Dr. Everett critiqued JELIS for the high LDL average and felt like statin should have been increased. This is very true, however without the statin increase EPA still lowered CV events. Goes both ways. Patients maximized on EPA to treat Trigs, could statins reduce cv outcomes further by decreasing LDL.
Another important point Amarin better get out, number of statin intolerant or statin intolerant to does increase!
God I hope Amarin reads this!!!!
Yes, the FDA should provide data that refutes or agrees with Amarin. But they failed to make a full presentation.
I believe the placebo issue was probable due to not enough washout time...either diet, fibrates, ... Continued to wash out after Study began increasing baseline to end of 12 weeks.
At this point I'd vote to wait. The FDA really F'd this up with no safety presentation.
Remember new AACE guidelines do recommend Omega 3. The FDA can't change that. They should be fair and change the labeling of niacin and fibrates they don't approve Anchor.
IMO the FDA is doing everything possible to torpedo this. The absence of a safety data presentation is absolutely incompetent when asking members to vote. Then FDA Dr. Smith reviews to the World the FDA considered safety moot because Vascepa is not a NME. Whether he was referring to it being already approved or comparing it to Lovaza is unknown.
Not a surprise our Government is planning to default tomorrow.
Did that MF FDA dude just say it not a NME?
Great news now that the AACE has come out with 2013 guidelines. Hope at some point the get mentioned, I emailed them to Amarin yesterday.
Yes, absolutely
3 Ad Coms.... But honestly Vascepas the only one I truly believe would save lives.
Thanks, only my 3rd Ad Com...;).
FDA is not worried about safety ....that's clear!!!! Celebrex
Risk & Benefit.
The FDA is actually making me fell better...that's odd.