Asking panel to vote on for which there was no data presented to them is unfair to the panel, sponsor and making a joke out of a govt regulatory body. They cannot be that stupid so other explaination is they're corrupt
Lowering TG would reduce CV risks, huh!
Before going into the panel, FDA knew study has only started per SPA so sNDA should be focued on saftey and efficacy.
Evidenttly they went ahead and asked that they should have at least qualified with what is the downside of approving it untl study is complete. More regulatory work for FDA (isnt that what you'r paid for along with other things) however could save millions of dollars in drug costs and if study holds could possibly save few lives too. There was no need for the panel. FDA can still fix it. I doubt they will though
no need to do any overtime. you can still buy some ah and double your money on thus
"We analyzed the last 13 FDA endocrine panel meetings, specifically the votes and relevant commentary from the 10 committee members on AMRN's Wed panel [and] we predict a 7-3 vote in favor of approval."
rumor has it FDA will approve as AMRN needs approval to continue and complete study in 2016 which is what FDA wants to see as well. Meantime save millions in drug costs for millions of people
than make no sense risks.
Good luck all!
12 week positive data with best in class saftey and efficacy profile and initiate the REDUCE-IT study.
AMRN can't continue this international global study without approval tomororw
It's in FDA best interest to grant approval, save millions of dollars something that doesn't hurt anyone and help AMRN finish the study in 2016 which is what FDA also wants to see
Link on yahoo finance amrn page
Write to FDA humble petition...
"...When I woke up this morning, I was asking myself, "Vascepa does no harm. High dose of that pure fish oil (4mg) will transform my blood components to more like those of my sons. Why not use it?"
FROM SA ROSS KLOSTERMAN ARTICLE COMMENTS SECTION...
"...here we have a drug that is completely safe and is far easier to take and tolerate then all the other CV drugs out there ...Statins, Fibrates , Niacin , Zetia ( I've taken them all )...and now we may be told to wait ?
Show me the Outcome trials that show the reduction in heart attacks using Fibrates , Niacin or Zetia ...as far as I know there are no ...yet they are all prescribed on label
So now we have a drug , Vascepa , that is by far a lot easier to tolerate , will likely show far higher patient compliance and possible save our health system millions if not billions of $ ...but no , we all wait another 2-3 yrs unless we can find MD's as enlightened as yourself....."
FDA CLEARLY STATED DURING TRAIL DESIGN UNDER SPA (paraphrasing from fda briefing docs)
"...Before an indication would be entertained for Ethyl-EPA as add-on to statin therapy in patients with elevtaed TG levels, the applicant at a minimum would have to provide results from a 12-week study with lipid endpoints as well as initiate an appropriately designed cardiovascular outcomes study.
They never asked study to complete to begin with. If they needed the study results they could have said to AMRN at the begining that this would be needed. I THINK DOCS CONTENT HAS BEEN TAKEN WAY OUT OF PROPORTION TO ENCOURAGE MANIPULATION. ITS OVER NOW OR IS IT?
“.....with rare exceptions, FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes." This should work in Amarin’s favor, especially since side effect issues were not raised....."