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Monday, October 31, 2016 8:28:50 AM
You need to read this to enlighten yourself...
https://en.wikipedia.org/wiki/Renaissance_Technologies
In life we are all going to make mistakes. It's not about fairness. In the market you are always going to be up against players more more money, more information, than you have..If you do not understand that, then you should stick to money market funds and saving accounts...
The AdCom ambush had nothing to do with Hamburg or her husband's trades..I was very long and very confident going into into AdCom..My initial reaction to what transpired was disbelief, anger, and later depression..I lost an unhealthy amount of my net worth. I was sure the company would sue for breach in the federal courts and be rectified. We know now that did not happen...as the FDA was able to stonewall the company's attempts...
Since that time I have come to grips with the situation and understand now the FDA might have acted illegally, but they did the right thing. In the long run it has worked out better for us as the PPS dropped so low we were able to accumulate much larger positions...It will, if R-I is successful, also benefit the company.
The reality is Vascepa needs to be confirmed by an successful outcomes trial. The real problem in the "situation Amarin" was Vascepa should have never been granted an SPA in the first place..That was truly the FDA's biggest mistake and it is highly unlikely Hamburg had much to do with that decision..V would have been granted access to over 35 mil patients as the first and only FDA approved drug for the mixed dyslipidemia indication..Where was the clinical proof of efficacy?..answer..There wasn't any. Only some very indirect indication that EPA could lower trigs and not raise LDL-C...The confronting the fact that no statin add on had ever been able to lower residual risk..and three studies that failed to provide absolute evidence trig lowering would lower CVD event risk...So the FDA was in the position of compounding an error which would have had a detrimental effect on health care costs..
Finally Hamburg's husband is second in command at Renaissance Technologies (RT), a hedge fund with more than $35 Bil in assets..
RT is quant based using computer algorithms to essentially do complex pattern recognition. Their strategies are for the most part "market neutral". RT is arguably the most successful hedge fund ever. Peter Brown (Maggy's husband)...is a billionaire..
In life we need to understand our own mistakes and benefit by improving our actions..The only thing we have any real control over...And stop blaming others for our problems..Time to move on to Cincinnati.
":>) JL
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