The AdComm members just declared that if your under 500, it is OK (yea, LDL vs HDL is important).
This SPA was about a set of target issues set up by the FDA. It seems that the AdComm changed the key issues of the panel.
The 1st thing my cardiologist does is blood work, and if my number is over 200, he starts a talk that says it needs to be around 180....Why? The panel just said that my 'number' means nothing unless it is around 500.
This just doesn't seem right ! The panel just changed a key diagnostic point in heart health medicine...that is not their job.
Point is there has always been medical theory that high trigs contribute to CV events but never solid clinical proof-Outcome study would determine that--Does taking Vascepa+Statin improve CV events?
We know it wouldnt hurt to use using Vascepa+ Statin but does it help? Only a clinical study can give certainty and that was panel members dilemma.Also,since Vascepa is already approved,drug could be used off label anyways an panel members are fully aware of that possibility-Almost seems things would have been better if Vascepa wasnt approved yet. There would surely have been no harm in giving a positive vote but the panel members were being tough and we all knew positive vote was risky...
I know many point to the SPA Amarin had with FDA, but FDA sadly can do as they please and break their own rules with little or no repercussions.
You really thingk kkllfla is going to understand your post when he doesn't even know the difference between cholesterol and triglycerides? I applaud your effort, but kkllfla's eyes glazed over when he hit the seventh word of your post. He is picking his nose and eating it as we speak.
The FDA screwed this up royal. At the end one person kept asking for the question to be repeated and explained becuase she was confused.
All that this meeting should have been for was to expand the use period, not to prove that it prevents heart attacks.
I have seen some interesting AdCom meetings before but this one was the absolute worst. If the FDA truly cares about the value and benefit of the Reduce It study and V in general, they should take a very long hard look at what just went down. Not to mention what other biotechs will think after the treatment AMRN recieved after having an SPA.