MASS LAYOFFS

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Anonymous said:
Seriously! As mentioned before from a very insightful poster,no one on this board has any idea what the adcom will do. Let's get this straight. The adcom can advise for or advise against and the FDA makes the final decision. The following is cut directly from the FDA website.

Advisory committees provide independent advice and recommendations to the FDA on scientific and technical matters related to the development and evaluation of products regulated by the Agency. CDER requests advice from advisory committees on a variety of matters, including various aspects of clinical investigations and applications for marketing approval of drug products. Committee members are scientific experts such as physician-researchers and statisticians, as well as representatives of the public, including patients. Although the committees provide recommendations to the Agency, final decisions are made by FDA.

Now, this is the important part. The FDA is a governemental organization. They exist, primarily, to help keep us safe. And like any bureaucracy, they continually try to prove they are relevant. The advisory meetings serve a fantastic purpose. They give experts the opportunity to give input, but as noted above, the FDA has the final decision. Since the bureaucracy is in place, they can't just meet and say," Hey this fish oil rocks, let's approve it. Slam dunk!" They have to do something, and what they do is ask questions. The questions are pretty simple to answer, it is much like us in the field when we have doc that is really engaged and challenging us. It gives us an opportunity to really explain things. We have, or actually Harold Bays, has the oppotunity to explain things. I cant think of a better person than Harold Bays to explain the ANCHOR trial.

This is a great drug, is very different from Lovaza, Niaspan or the fibrates. Plavix had a 19% RRR when added to aspirin in the CURE trial. When the JELIS data is explained, and the commonalities between Vascepa and Elipat are explained, this committee will see the light. 99% of what we are reading today is the ANALYST who make are making money on the panic driven moves we make.

Everyone needs to relax and see waht happens Wednesday. We may have some additional questions to answer, good. It means they are interested.
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And here is a post by someone that was stupid enough to buy the hype/stock and will now lose what little money he has left.
 
























Anonymous said:
It does matter because it is the more immediate concern. Generic Lovaza could be ways out from hitting the market, but the meeting next week will have an immediate impact.
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Uhmmmm......no. The generic for Lovaza is only months away. The generics were filed several years ago and were held up by the remaining patent. Since the appeals court has reversed the decision, the final review can take place.
 






























You sick a holes that enjoy bringing others down are not bringing me with you, you pitiful pathetic jerks that take pleasure by seeing others suffer are sick. What empty shallow humans you must be to have nothing else to do. My god go jerk off or something!!!
 






























The product is selling....and growing. The FDA impact may be weaker than we anticipate. The data does illustrate its superiority over Lovaza.

I intend to hold this stock until the story is complete. I'd bet it gets purchased by another drug company at this price.
 






Anonymous said:
The product is selling....and growing. The FDA impact may be weaker than we anticipate. The data does illustrate its superiority over Lovaza.

I intend to hold this stock until the story is complete. I'd bet it gets purchased by another drug company at this price.
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You seem like the type of investor that would be interested in buying some swamp land in Florida. The time to sell this stock was long ago. Some other company may buy it at like $2 per share if you are lucky.
 






Anonymous said:
You sick a holes that enjoy bringing others down are not bringing me with you, you pitiful pathetic jerks that take pleasure by seeing others suffer are sick. What empty shallow humans you must be to have nothing else to do. My god go jerk off or something!!!
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Thanks for the suggestion. I am jerking off on my Amarin stock options since they are worth about the same as a piece of tissue.
 
























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