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Fast Track, page-2

  1. 4,294 Posts.
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    Denial,

    Enjoyed your summary.

    I have heard in terms of pure blocks of time, for a typical drug (are we atypical?) the time saved is after Readout but before licencing. Normally this can take up to around a year. A Fast Track proposition can reduce this by around 6 months...sometimes a fraction more. This is why I wasn't too surprised when Donna mentioned that we prob would look more seriously at a FT later on, or she said words to that effect? I understand Paul interjected saying we could apply earlier.

    I was always wanting the co. to apply earlier. I had asked this of them years ago...but I also thought the main benefit is the bloc of time saving as mentioned.

    Of course the other benefit as others have pointed out is the Rolling reviews and the dedicated FDA liaison and just the entire increased focus the FDA will now have.

    A wonderful announcement, think I will need to have a scotch on the rocks tonight.

    (Use alcohol wisely)


 
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