Question for Bear or anyone else regarding US drug legislation.  Does anyone know where the 21st Century Cures legislation is sitting?  I have been wondering if by the time RVX gets EMA approval and if that legislation is in place, will RVX even need to go through the whole process to be able to get approval to sell in the US?

Further to this, while I wouldn't say I'm greatly knowledgeable about approval processes in general, I do know that life goes on outside the US without the FDA. One company that I have followed for years is Cardiome which about 8 or 9 years ago was denied by the FDA after a successful ph 3.  Their drug, brinvaness, has been selling for quite sometime now in much of the EU and other parts of the world (about 30 countries now) and was recently approved by health Canada, still no FDA approval.