On the Teva analyst day there was a question regarding that. Teva management indicated they did not think more data would be required to file (in the US at least) and were in dicussions with FDA as to whether it would be an sNDA or NDA. I have a question for anyone more knowledgeable in this things. If it is approved what would be the difference in how it is was filed (i.e. is it more preferable to go one route vs. the other?)
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.