We got it!!!!!! Awesome....3 months to approval now.
Sentiment: Strong Buy
Coppi, where's the beef?
Did they, or did they not guide to a class 2 submission? Why do you think they left that out? Behind close doors discussions maybe? DO I ALWAYS have to spell it out for you!
very possible. imagine the... biggest short squeeze in history is in the making.
is this why they were able to submit NDA while gov is still shut down?
FDA was accepting submissions that are fee-based (which I assume this is) - revenue coming in they will accept.
Where did you find that out?
relax, gents, its in the bag. FDA owes us one.
Please don't post lies, there are enough liars on this board already. Do you want to be known as a liar?
Source please - other than a Magic 8 Ball