That one is easy. You get it on record before,
Post# of 148235
You get it on record before, or along with, the lawsuit for damages. Hard to claim that you believe Amarex cost you an approval if you’re still using the BLA based on their work.
Now it’s not just, “you did a bad job and we had to redo a lot of your work before we could clean it up for approval” and it’s shifted to “you did such a bad job that we’ll never be able to gain approval”
The difference in damages between those two scenarios is substantial.
And we “had to” write off usable drug because of the delays. Which is why I think they went ahead and wrote that off recently when they could have waited another year or two.