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  • taserblast taserblast Oct 8, 2005 9:36 PM Flag

    sBLA approval - 3 months (see example)

    Some people here are posting crap about the time line for sBLA approval.

    There is a difference between BLA vs. sBLA

    BLA (Biologics License Application) takes longer

    sBLA (supplemental Biologics License Application) is a shorter process.

    Here's an example of FDA speed for sBLA approval:

    Feb. 2004 - FDA approved Genentech's Avastin

    April 2004 - Genentech announces it will expand Vacaville Product Operations in a groundbreaking ceremony attended by Governor Arnold Schwarzenegger, as well as city and county officials. The expansion includes three new manufacturing buildings comprising 380,000 square feet, and one new 135,000 square foot administration building.

    End of May 2004 - Genentech files sBLA (supplemental Biologics License Application) so that Avastin could be manufactured in Vacaville

    August 11 2004 - FDA approves sBLA

    ** Less than 3 months is possible for sBLA approval. **


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    • The FDA was kept in the loop since the withdrawl, as stated by KM and then by JM.
      I would expect a relatively quick approval of the sBLA. Sooner than 3 months. I think everyone will be surprised and caught off guard.

      • 1 Reply to gixer907
      • FWIW....

        It is my humble belief if we get the "Priority Review" acknowledgement from the FDA it will indicate likely approval. Unfortunatly, the FDA seems to take the entire 180 days, +- a day or so, to finally send the official word. While I hope this is not the case for the sake of the entire MS community, I am prepared to watch our slow ascent to improved valuations during that 150 day sandwich period as Tysabri's credibility will slowly but surely begin to be restored.