I am surprised at how everyone is shocked at the announcement of FDA's notification. After the FDA vote question and outcome of the FDA panel meeting, the notification by the FDA was the only reasonable outcome that could have been expected. We need to stay calm and react responsibly to this announcement and take appropriate action, whether that may be selling the shares or doing all possible to support the company through the Reduce It trial. When the FDA panel voted no, per their guideline, FDA had to notify AMRN that they are reneging on the SPA due to change in science. This was required step to break the SPA based on FDA written guideline . Next step is for AMRN to request a type A meeting to discuss the breaking of the SPA and for further discussions on the matter. As far as I am concerned what happened was completely expected step that FDA had to take. Personally, I made the decision at the time of the Panel meeting that I will see through the Reduce It study. In my view, based on all the evidence that I reviewed there is still a very good possibility that the Reduce It study will show a positive outcome. My main concern is that they will not complete the study- to me this will be a disaster.
I do think that this is the time to take every action possible to let the FDA know that we the public disagree with their actions to renege on the SPA and put maximal pressure possible to influence the PDUFA outcome. Of course, this would be an uphill battle but as a share holder it is an action we can take that might influence their decision. I will be submitting my letter to the FDA expressing my disagreement with their decision tomorrow. I would hope that others do the same. This is the time to take stock and fight the decision not grieve. We need to do all we can to help vascepa get approved.
Although there is great deal of doom and gloom, there are good possibility going forward (if or when FDA gives a CRL) that a BP could partner for the Reduce It study or buy out the company at a bargain price- it would be a bargain price for great potential- the risk and reward may be compelling. There is also a possibility that the interim data could be overwhelmingly positive.
My point is that the actions of FDA were completely expected and logical. Our investment thesis must also be based on good rationale and our response also logical and appropriate. Although I wish we had a positive panel vote and FDA didn't violate the SPA, but FDA did and at this point we have to make a decision to sell or hold through to the Reduce IT. I am holding and I am fighting the FDA in what small way that I can.
