In all seriousness, this is the end of the road for AMRN. They are really caught between a rock and hard place with nowhere to go.
1. They have to continue REDUCE-IT to have any chance of future success, but, lets face it, Reduce-it is unlikely to show the desired results
2. No matter how good a drug vascepa is they cannot sell it WITHOUT A SALESFORCE
3. Nobody will buy them out because "they want to be bought out". For example, you may pay $500 for a shirt in Neimann Marcus, but if a homeless beggar on the street offered you the same shirt FOR FREE, will you take it - PROBABLY NOT.
4. In short, all roads lead to hell, the choice is yours.
5. The only question is how quickly will AMRN fold up.
Good luck with other investments and sincerely sorry for your loss
lap ... R-I is 2 yrs out ... and that's providing they can come up with the $$$ to go forth ... BP knows this and has them exactly where they wanted them yrs. back .... the company needs to do the right thing here ... for the investors sake.
I too am speechless. Just what is the FDA saying? That purified EPA is worthless for those with trigs less than 499 or that reduced CV events must be proven before consideration to approve? Does this suggest that all of the advertisements, and advice from cardios to include Omega's in ones diet is to be ignored or just a waste of money?
I just don't believe their position is consistent with the large body of evidence suggesting benefit is real. Sure Reduc It study seems worthwhile but funding should come from those involved in this industry as it surely will negatively impact all of them somehow. And given all of the other suggested marker gains, such as inflammation, it just seems to offer too large a "potential" benefit to such a large population that it should be on the market for the duration until R-it is completed, particularly with such a clean safety profile.
This is preventative med at its best. What is the FDA thinking?????????
The FDA can do whatever they want. Nobody can really stop them. They don't care that AMRN spent millions following their SPA and GOT THE DESIRED RESULTS, only to have the SPA rescinded. My heart goes out for AMRN.
Does this mean that Cardiologists will no longer consider this category of drug for high trig patients?
The FDA decree infers that Cardiologists should not prescribe EPA/DHA drugs for their patients in this catergory. This really makes no sense.
The FDA should throw ARMN a bone, and approve 300-500 trig levels for this drug WITH NO label reference to reduced CVD's. It works great, its safe, and yet this hatchet job by the FDA may be a death blow.
It just feels strange that without REAL DEFINITIVE new study results, they overturned all the prior work on this treatment approach for at risk heart patients.