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Northwest Biotherapeutics, Inc. Message Board

  • sentiment_stocks_trader sentiment_stocks_trader Feb 27, 2014 2:18 PM Flag

    From Ihub regarding the delay in DMC results

    John1045 - the moderator on ihub makes some good points here

    We are now just short of 12 weeks since December 10th PR. This being a Phase III international trial with US, UK and Germany regulatory issues if PFS data is meeting Primary Outcome of 6 Months then you now have a number of discussions on next steps to take due to the three regulatory bodies overseeing this trial in their country. IMHO...something is going on as a simple continuation would not take 11 weeks for a decision especially since this is not 500-1000+ patient trial. I could be wrong and we could just get a continue but my instinct is telling me different. JMHO

    If the DMC requests more information - responding to that is probably a monster task - asking this from all locations the trial is being conducted - and then relying on them all to turn it around quickly - probably not going to happen like that.

    Sentiment: Strong Buy

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    • Well, if it wasn't for the recent run-up, I'm also now leaning that the delay this is a positive thing.

      But honestly, I'm really not sure but I am hoping for the best as I'm up and been holding since the low 3's.

    • Probably BAD NEWS! We need to sell all our long positions and short the stock!

    • pepperoniandmushrooms2003 pepperoniandmushrooms2003 Feb 27, 2014 4:23 PM Flag

      thanks !

    • Agree.

      The DMC typically has 3-7 independent members, at least 1 statistician and likely 1 ethicist or patient advocate. If the early progression free survival and incidences of death are close to the DCVax-L Phase 1/2 results in this larger population over 50 sites, then at a minimum, the ethicist or patient advocate will push strongly for a termination of the trial and to move all control patients to DCVax-L. In a way, that is what UK did by allowing Compassionate Use in UK, and expecting the same in Germany shortly. This is not a live-with-pain or not decision; this is about making a decision on whether GBM patients live or die with relative certainty.

      GBM is fast, deadly, and uncurable (without DCVax). The median survival without treatment is 4.5 months. With SOC treatment, median survival is 15 months. Per the National Brain Cancer Tumor Society, only 4% survive for 5 years, meaning most die before then. None survive past 80 months. It is only with DCVax-L that we have 1 patient surviving 11 years and 1 at 10 years to-date, with more to come, ie DCVax-L patients currently in the 6-9 year range. The p value on DCVax-L Phase 1/2 was 0.0003, meaning less than 3/100th of 1% chance the outcome was due to chance.

      My guess is there is a good healthy debate at the DMC going on right now, between Very Good or Great. As time passes and as we enter March, the odds of it being Great are much much higher.

      Sentiment: Strong Buy

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