Probably dumb question, it is clearly bothering me.
At annual meeting in the contect of being conservative as to needing partners for FOB and novel drugs as well as maintaining a significant cash balance, MNTA CEO Wheeler made a pretty big deal of the possibility of future competition to mLov TEVA and from companies other than TEVA. He said several times that the market is just too big to prevent companies from considering entering the market. He also said that there may be pending "paragraph 3" applications that could be approved at any time. He went on to describe the paragraph 3 rules to apply when there is no patent protection to worry about (as is now the case with Lov).
Has anyone seen approvals "come out of the blue" on other drugs under paragraph 3? Or is Wheeler being overly conservative (in part to undermine the Palo Alto argument that he knew would be coming later or otherwise)?