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Provectus Biopharmaceuticals, Inc. Message Board

  • vorlon1966 vorlon1966 Feb 1, 2014 10:36 AM Flag

    BTD Application

    I have been told that when the application has been sent in there will be a press release stating so.
    That will start the 60 day clock.
    There will be that 30 (really 30-50) day waiting for the minutes after that. What happens at the next meeting?
    Since it was the FDA that changed the target label to recurrent melanoma and made the treatable indication wider for more patients, then there is but no other answer I can see other than the FDA likes it, wants it, even said so, and wants more patients treated with it. To me the odds of approval would seem to be extremely high. Make your own mind up on that.

    After the meeting? Its either an accelerated approval or short bridging study. What is a short bridging study? A short 1-3 month study to bridge the data from what they have to what they need to complete the required amount of data for the FDA statistical model. This is not a Phase III study.....I know this because I asked what a bridging study might look like.

    And after that? New Drug Application filing (NDA). Well guess what? They have been doing a lot of that work already. Three big reproducible product runs at a cost of $1.2 million (per Mgt at two conferences)....Done!
    Drug interaction study for the label.....that report just came out...done!

    After the NDA?....a meeting here and there AS ITS GOING OUT THE DOOR.
    After it's on the market then there will be a Phase IV study that lasts ten years to observe patients survival.

    I do know that they have been working their butts off to get this application ready.
    I think it will be announced soon.

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