On the 011 P2B, I think everybody agrees that failure to be stat sig is not the end of the game.
I would say though that it needs to show more than "the same or better" as a point value. Something like 15% vs 5% would make me happy (and not be stat sig).
On India, the FDA will not balk just because of the India locations. They will keep a close watch on that though, so the danger is that the locations actually do have serious violations and anomalies.
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.