What now?

There a few instances where FDA went against adcom. 2 were for cancer and the other was for hypertension.

Does anyone know the language that the adcom voted on? Sounded like they voted on Vascepa with Statin to reduce CHD events. If that is the case, I understand the no vote and wait for Reduce it. Is it possible to still negotiate with the FDA for labeling for reduction of trigs 200-499 in mixed dyslipidemia?

We're you on the call last night? Amarin said they have NEVER went against the adcom. Put the kool aid down and wake up
 












We're you on the call last night? Amarin said they have NEVER went against the adcom. Put the kool aid down and wake up

I was on the call and he said that the FDA has never violated an SPA. He said that yes, the FDA has gone against the ADCOM recommendations several times, but it's an "uphill battle".
 












You need to go back and read the transcript. Amarin said they have not. What a duma$$ you must be

I did read it! Amarin said they've never gone against an SPA! I'm not being combative, but maybe YOU should read it. The FDA is not bound by ADCOM. Google that and you will find 3 examples of when the FDA has gone against ADCOM.
 






I was blind sided by this review from ADCOM. Im sure they are smart people but to have a product with fewer side effect's than aspirin it's unbelievable hear this decision. I hope the next round goes better. It would be very unfortunate for this decision to dictate who gets this great product and who does not based on criteria that is cookie cutter in nature and not based on solid end points. I would think anyone who read the studies and has a good grip on the cardiology market would be on this product in a heart beat. I guess some are blinded by the truth.
 






I was blind sided by this review from ADCOM. Im sure they are smart people but to have a product with fewer side effect's than aspirin it's unbelievable hear this decision. I hope the next round goes better. It would be very unfortunate for this decision to dictate who gets this great product and who does not based on criteria that is cookie cutter in nature and not based on solid end points. I would think anyone who read the studies and has a good grip on the cardiology market would be on this product in a heart beat. I guess some are blinded by the truth.

What is so great about his product? There is no CV benefits to this product and it is no difference in us and Lovaza. Why should a doctor change their Rx habits. The Anchor trial was fixed because we used mineral oil for the placebo which studies have proven to have a negative impact on a statin
 






What is so great about his product? There is no CV benefits to this product and it is no difference in us and Lovaza. Why should a doctor change their Rx habits. The Anchor trial was fixed because we used mineral oil for the placebo which studies have proven to have a negative impact on a statin

Please further explain the mineral oil effect and the studies supporting it.
 






What is so great about his product? There is no CV benefits to this product and it is no difference in us and Lovaza. Why should a doctor change their Rx habits. The Anchor trial was fixed because we used mineral oil for the placebo which studies have proven to have a negative impact on a statin

Where is your evidence for mineral oil effect? Remember the 2gram/day would have taken both placebo and Vascepa. Mineral oil is not absorbed so only potential effect would be impact on statin absorption. 2 gram dose still had benefit compared to placebo only so not likely affecting statin absorption.

You say "we". You really work for Amarin?

Do you really work in Pharma? You say "why should a doctor change their Rx habits." seriously?, that is your job to get the prescriber to change!
 






Change prescriber habits?

I can only speak about the PI

I do not participate in profits generated by patients filling prescriptions

My job is to show up, bring cupcakes, watch the ladies make fun of me, have the MD not see me, walk to my car and write a story.

End of Story
 






Change prescriber habits?

I can only speak about the PI

I do not participate in profits generated by patients filling prescriptions

My job is to show up, bring cupcakes, watch the ladies make fun of me, have the MD not see me, walk to my car and write a story.

End of Story

You must be a blast on your kids career day at school!

If you are in sales then you have selected the wrong career.

What does "I do not participate in profits generated by patients filling prescriptions" mean?
 












Bye Bye you non selling a$$holes. Your efficacy data sucks when compared to Lovaza and your message of ldl increases got you less than a 5% market share. GSK has made its money in the SHTG market and soon Lovaza, the market leader, will go generic. What does that mean for your company, more downsized reps. Keep your Vescepa samples because all of you will be unemployed and unable to buy salmon to get your Omega 3.
 






I was blind sided by this review from ADCOM. Im sure they are smart people but to have a product with fewer side effect's than aspirin it's unbelievable hear this decision. I hope the next round goes better. It would be very unfortunate for this decision to dictate who gets this great product and who does not based on criteria that is cookie cutter in nature and not based on solid end points. I would think anyone who read the studies and has a good grip on the cardiology market would be on this product in a heart beat. I guess some are blinded by the truth.

You resemble the people who drank the kool-aid at the Jonestown massacre
 












Nice spin. Well how do you know which patients were put on statins? Placebo LDL isn't affected because you aren't balancing the lipids. When LDL went up on treatment arm, statin was used.

Shitty a$$ wanna be!

Have fun taking your assessments and simulations at Gsk! And don't forget to get every box checked on your Cots :)
 






This is coming out of the home office. If you are one of the smaller territories please start looking for another job. Remember what they said last night, the FDA has never gone against the adcom before. I am not sure if the cuts will have soon or if they will wait until December. Don't believe the BS that will be coming out of the home office.

That is not true. The FDA has definitely gone against the advisory committee vote in the past.
 


















Nothing has changed for me, same indication same doctors, had record scripts this week!! Sorry shorts. We hit a small bump in the road, big deal. I can't wait till Monday morning to gain more marketshare!!

Saw my Lovaza rep today he told me they don't give a rats ass about Lovaza now! Ha ha