OPC,

Hakan said in response to a question from the Leerink Swann analyst: 'We are not in discussions with EMA as we speak, however, as we are preparing documents for the US submission we certainly are keeping EMEA submission in mind whether...'

My problem is with the 'so to speak' part. You're either going to submit or you're not. Why hasn't the company submitted to the EMA before?

I think this goes to management. Keep in mind OPC, this just my opinion, but if you have a blockbuster drug, which I suspect AFREZZA is, and diabetes is a world wide problem, not confined to the US, then a solid management team would be seeking approval not only from the European agencies but Asian agencies as well. The problem, as I see it is that if we rely on the 10-15 year approval process of the FDA we'll never get anywhere. The approval process in Europe should have started upon the receipt of the first CRL...and certainly after the second.

Again, this is just my opinion, but I think I would have been more aggressive in seeking approval somewhere in the world, where an agency (maybe the EMA) would recognize diabetes as a problem that needs to be addressed now and not ten years from now.