linhdtu's reponse is far better than what I was actually thinking. When I wrote that comment I was thinking about how almost everyone seems to have been completely blindsided by the FDA's approval. That includes Amphastar, Watson, Momenta, analysts and this message board.
Obviously Amphastar was blindsided else they would have been ready for an immediate launch as Sandoz was.
If the sponsor was blindsided, how can anybody else outside of the FDA expect to forsee it?
I was thinking about how almost everyone seems to have been completely blindsided by the FDA's approval. That includes Amphastar, Watson, Momenta, analysts and this message board.
Here's my post from 2010 quoting Amphastar as saying they had achieved sameness and that the remaining holdup was presumably immungenicity and supply:
Their claim was pooh-poohed by posters on this board at the time, but in the light of subsequent developments it appears it was likely accurate. So I have no reason to doubt that they are ready to launch in limited quantities if the TRO is lifted. I really think people are grasping at straws here.
As far as I am concerned, the only remaining substantial uncertainty is whether MNTA can demonstrate Amphastar is infringing during the testing in the manufacturing process.