Ann: Nyrada Commences Walter Reed Traumatic Brain Injury Study, page-55

  1. 1,793 Posts.
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    GLP results coming up which are already de risked and then we move into phase 1 and Walter reed which is derisked from 2012 pre clinical study then FDA submission in Feb and then phase 2 with funding from the US defence force.

    You have made every single thing up.

    The US Army aren't paying for a stage 2 trial. Christ alive, Walter Mitty would turn in his grave.

    FDA submission??

    What are you submitting mate - do you know?

    I'll tell you - you are asking them for permission to do a human trial. An IND application.

    You are not de-risked. I don't know why I'm bothering as all you do is keep repeating the same silly things over and over again.

    https://www.fda.gov/media/82381/download

    You are at stage 1 of 12 steps

    It clearly states:

    Trial cohort numbers

    Stage 1 - 100 patients

    Stage 2 - 300 patients

    Stage 3 - 1000+ patients.

    You are at the very beginning of the FDA journey, and as I've pretty much shown you to be a bloke that has absolutely no idea what he's talking about, I'll leave this here.

    To everyone else - here is the journey ahead - you are at Stage 1 on a 12 step journey that will take 10+ years.

    Please read THESE: https://www.fda.gov/media/82381/download

    It takes 10 years minimum from where Nyrada is now to gain approval - often longer:

    https://lifesciences.n-side.com/blog/what-is-the-average-time-to-bring-a-drug-to-market-in-2022



    Lastly - you know how many drug start-ups that fund these trials themselves?


    1 in 1000 - yes, that's all - 0.01%

    You aren't going any further on this journey without a big pharma company. You are about $200,000,000 short of funds.

    Best result would be a 50% share of the company in exchange for trial funding.

    Worst - they buy you out when the SP is at rock bottom.

    AGN has nothing to do with this.

    $10,000,000 in the bank has nothing to do with this.

    Read the FDA info mate and stop telling porkies to people - you have absolutely no idea what you are talking about, and some people here seem to think you do. You don't.










 
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