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FDA delays approval of IntelGenx, RedHill migraine product (IGXT)

  • The FDA has told IntelGenx (IGXT) and RedHill Biopharma (RDHL -2.8%) that it won't yet approve their VersaFilm oral film treatment for acute migraines, due to issues over third party manufacturing, packaging and labeling.
  • However, in a complete response letter, the FDA said it accepted the bioequivalence study and safety information submitted, and that it requires no additional studies.
  • IntelGenx and RedHill intend to address the FDA's concerns within weeks, and to advance discussion with potential partners for the commercialization of VersaFilm.
  • In addition to seeking FDA approval for the product, IntelGenx and RedHill intend to file for European authorization later this year. (PR)
Comments (4)
  • joshihotels
    , contributor
    Comment (1) | Send Message
     
    IGXT stock price has tremendously upside due to news and strong possibility of a $3-5 buyout. Great Stock to buy on the way up.
    4 Feb, 12:12 PM Reply Like
  • roboterotze
    , contributor
    Comments (6) | Send Message
     
    You read the bad news today, or ?

     

    At first IntergenX will lose 3,4,5,6 (?) weeks until the final approval..
    4 Feb, 04:31 PM Reply Like
  • villagorgona
    , contributor
    Comments (3) | Send Message
     
    we overcome the big setback ,its buy stock no doubt.
    4 Feb, 07:13 PM Reply Like
  • alikhan2006
    , contributor
    Comment (1) | Send Message
     
    Most likely third party manufactering issues is going to be resolved. Be optimist!
    17 Feb, 05:51 PM Reply Like
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