Iron Mike, I agree that we should be told when any application for approval is accepted, but I have no idea how long the regulator is permitted to take. If the regulator requests a change I don't know if they'll act quickly once that change is made and submitted, or if they'll take the full review time.
The company will never say that they've been asked to make changes, I believe the SAP took substantially longer than anticipated because with 4 regulators to satisfy with essentially the same document every requested tweak had to have the approval of all four. In that each regulator gets their own application, at least any requested change shouldn't require the blessing of the other 3 regulators, this process ought to move faster.
All speculation is that it's the U.K. that's first, but we really don't know that. In the case of the U.S. there aren't a variety of steps as I understand it, the BLA essentially contains everything. If I'm correct about that, it's possible that submissions are being made at essentially the same time.
Normally it's best to PR good news early in the week, while dumping the bad news after the close on Friday's. Really bad news is often held to be dumped after the close on a three day weekend. I suspect the company won't hold back the issuance of a PR on the acceptance of a regulatory filing, and I believe it could come any day.
Gary
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