MAP Pharmaceuticals (MAPP) says the FDA has issued a Complete Response letter to its New Drug...


MAP Pharmaceuticals (MAPP) says the FDA has issued a Complete Response letter to its New Drug Application for Levadex. The FDA didn't cite clinical safety or efficacy issues, nor request any additional clinical studies be conducted prior to approval. It did however, request the company address issues relating to chemistry, manufacturing and controls and observations from a recent facility inspection of a third party manufacturer. Shares +7% AH.

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Comments (3)
  • DougRk
    , contributor
    Comments (1901) | Send Message
     
    Where are you seeing +7% AH? It was +7% during regular hours, then trading was stopped.
    26 Mar 2012, 10:27 PM Reply Like
  • BOXNMN2K3
    , contributor
    Comments (2) | Send Message
     
    dsr70, you are right, it was +6.92 during regular trading hours before it was halted ~2pm, so I don't know where this +7% is coming...hopeful thinking :)
    26 Mar 2012, 11:29 PM Reply Like
  • DougRk
    , contributor
    Comments (1901) | Send Message
     
    Hopeful indeed, and I was hoping too. I'm going to be burned tmrw :(
    26 Mar 2012, 11:36 PM Reply Like
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