Yeah no doubt BD will require FDA approval, but LBTs FDA...

Yeah no doubt BD will require FDA approval, but LBTs FDA approval has now set the precedent and process on which successive applications will be assessed. In my humble opinion I imagine the process to FDA approval for successors will be shorter as the books won't have to be re-written or new classes and their descriptors created.

But like you i'm sure as hell no expert on patent or FDA processes! I'm just a microbiologist thinking out loud..

For comparison consider the story of our glorious Previ Isola.. First to market, patented and FDA approved. Now what's it doing? The much larger competitors caught up..patent protection only meant that couldn't make an exact copy. I worry APAS will play out the same