Amphastar uses techniques that infringe MNTA's patents to demonstrate sameness, and using these techniques, they get approval. But they also show that if they monitor their 7 (non-infringing) elves closely, they always have sameness, and going forward they manufacture using these 7 elves only.
Possibly, but very unclear and I personally doubt it would fly. The problem is that you now gave a second level of indirection in establishing "sameness". I suspect the FDA would want to see some level of QA that directly establishes the sameness of the product.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.