CO,
I agree that quarterly calls right now are nearly worthless, but that's because we're in a quiet period and have few if any Analysts following us who'd typically be the ones permitted to ask questions in a conference call. This all will change once we're on a major exchange and pick up Institutional investors and Analyst coverage.
We're in sort of a Catch 22 situation, we have no control over those who decide when to publish the Journal nor do we have any control of the regulators. If one is in any way waiting for the others, we have no leverage either way.
What we do have influence over is the submissions we make with the regulators for approval. The regulators have the choice of accepting out submission, or asking for some change, but it can't simply be ignored. Once a submission is accepted it should be announced, and then it's a matter of time until a regulatory decision is made. Of course approval is never certain, though I believe our chances are very good, but I've seen many drugs I was sure would be approved delayed, but in the end none were denied.
If I had to put a percentage on it I'd say the U.K. is 98%, Europe over 90%, Canada 80% and the U.S. 70% likely of approval without significant delay. I view significant as over 6 months. I do not believe any regulator will deny approval, but a significant delay is certainly possible with any one of them.
Gary
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