Foxhound,
How many BP's time new products to when old products are coming off patents. I'm not saying it's right, personally I wish they'd rethink the whole patent idea so improvements can add to the applicable time, but that's not the case. Clearly if companies have a product that doesn't have upcoming competition, they'll hold up improvements they could make until patents are near expiration.
I believe that NWBO is working to time things properly, but if a few months delay assures approval as manufacturing questions are answered I'd prefer that to having to fight for approval without it, then need to get it authorized later.
Gary