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Novo Nordisk (NVO) shares plunge 11.85% premarket after the FDA unexpectedly rejected the...

Novo Nordisk (NVO) shares plunge 11.85% premarket after the FDA unexpectedly rejected the company's Tresiba long-acting insulin and a related product called Ryzodeg. The FDA requested more data from a dedicated cardiovascular outcomes trial, which Novo doesn't expect to be able to provide this year. Tresiba and Ryzodeg are approved in Europe and Japan, and are forecast to generate billions of dollars of sales - assuming U.S. approval.
Comments (10)
  • The power of FDA. Approval from EU and Japan implies almost approval from FDA.
    Is it political or scientific.. Somebody, who is closer to this research and technology would help us understand....
    11 Feb 2013, 05:27 AM Reply Like
  • What a strong pharma stock

     

    Anyone buying this pullback?
    11 Feb 2013, 07:15 AM Reply Like
  • Yes, but one wonders if there is further selling. NVO was trading at a 52wk high above many price targets before this drop. I'd like to at least see it pull back to the $160 level.
    11 Feb 2013, 11:18 AM Reply Like
  • it's slowly dying as the day goes on. Below $165 now....
    11 Feb 2013, 11:55 AM Reply Like
  • (puts his morning soda away).
    11 Feb 2013, 08:18 AM Reply Like
  • Wow! The FDA wants a cardiovascular outcomes study for a new insulin product? That's insane. That is beyond cautious.
    11 Feb 2013, 09:28 AM Reply Like
  • Definitely buying on this pullback. I've wanted to add to my NVO position for a few months but felt it was getting a little over heated.
    11 Feb 2013, 09:29 AM Reply Like
  • Agreed with jrobins. This is not really an outright rejection, it is a delay/request for additional information, for which Novo management was clearly not prepared. it's a good opportunity to add.
    11 Feb 2013, 01:18 PM Reply Like
  • Bought more shares and a few options, thanks FDA!
    11 Feb 2013, 02:14 PM Reply Like
  • Ok I took the plunge. Should have some the same for sny a few days ago :)
    11 Feb 2013, 06:05 PM Reply Like
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