ISIS is dead in the water. EMA didn't respond by deadline, something wrong.
The EMA missed the deadline for ruling on ISIS so there must be something wrong there. Whatever put off the EMA may very well require ISIS to do additional clinical trials to prove safety. This leaves AEGR standing alone in the market.
Add to that the successful EU patent, where there were no problems or delays and it becomes clear that the EU & EMA strongly favor AEGRs approach as much safer and more effective.
ISIS has significant hurdles to overcome and will be way late to the market, where AEGR will be firmly entrenched.
I agree with you. To my mind the issue isn't about aegr's pending FDA approval. It's about (what I think) is FDA's pending rejection of ISIS's drug. It was a 9-6 vote. And one doc admitted his was a 'weak yes'. I think that makes this an 8-7 vote, and there is simply too much around side effects for the FDA to say yes. So AEGR will have the market to themselves, until Regeneron's blockbuster drug comes out.