HDG & JL
Please understand their are many ways to view situations. I for one agree with Bio that the FDA did point blank screw us back on Oct 13th.
Both of you look at it from a medical viewpoint which you are 100% correct. The FDA realized their mistake and found ways to circumvent the situation not to give AMARIN 35 million potential subscribers without positive results concerning trig lowering to lowering cvd events.
I look at it from a business viewpoint as does BIO that the FDA set up and agreed to an SPA with AMARIN. AMARIN was, an is a small company required to run a 7000 modified to an 8000 CVOT study costing approx. $250/300 million.
This study called REDUCE-IT would take approx. 4 years to complete and that cost would be mitigated by sales from ANCHOR approval. The FDA knew that they would be harming AMARIN by rescinding the SPA, "THEY DIDN'T CARE".
They could have modified the SPA 6 months prior to the ADCOM as Bio has stated. Hdg you said maybe AMARIN was informed and proceeded anyway, which could be true. I think the FDA hedged their situation through out the process knowing the power they haD (my opinion).
Now we are 4 years into the study near the end with double the number of shares from approx 170 to 340 million potentially issued. Those shares paid for REDUCE-IT hurting all original investors.
YES, this is now water under the bridge with results forthcoming. YES, we need to put this behind us and look to the bright future ahead. But as investors, we were hurt badly with many of us still under water so to say. PLEASE don't give the FDA any positive credence for what they did.
