Announcement

Collapse
No announcement yet.

DCVax

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • DCVax

    This is the place to talk about the recently revealed results of the long awaited results of the double blind, randomized, placebo controlled Phase III clinical trial with DCVax-L for newly diagnosed GBM! To see results go to virtualtrials.org/dcvax

  • #2
    The results are now up and they look great! The only result that doesn't appear at first to be great is the progression free survival compared to the placebo.. but in reality - that is a positive. All immunotherapies create swelling and inflammation which is really pseudo-progression. But the overall survivals were much better. Especially that tail! They did a great job of creating a matched synthetic control group. I have never seen so many factors considered!

    Comment


    • #3
      Sorry, posted that in the wrong place. My question is, if the results were so good for this trial, why did the stock plummet?

      Comment


      • #4
        Excellent question. I have no idea. But I have learned that the stock market is rigged and easily manipulated and has nothing to do with reality. Look at Telsa. How could a company like that be worth 800 billion dollars? Same with Bitcoin - it is a worthless promise created by criminals for criminals and now has a valuation of over $1 trillion and it is completely made up.

        Comment


        • #5
          Hi, as I understand it this will have to go through an approval process before it's avaialble to patients? Or maybe FDA expanded access compassionate use for those that can't wait?

          Comment


          • #6
            This should be relatively easy to get fda appt. It is based on risk/ reward. Amazing results combined with no side effects means easy approval. The problem is the size of the application. It is hundreds of thousands of pages usually and takes forever to write and to read.
            Expanded access was available even before this data came out but the problem is the cost and waiting list. Insurance usually doesn’t pay until a treatment is approved and it is expensive to create the vaccine. They have a new facility that creates the vaccine so the waiting list should not be a problem. If you are interested, our patient navigation program can help find the cost and logistics for you

            Comment


            • #7
              Hi there, may I know why the presentation said "endpoints submitted to regulators before unblinding".. but does not tell if endpoints are accepted? It means PFS is still the primary? And why management does not file for SEC investigation against AF?

              Comment


              • #8
                The PFS is still listed on clinicaltrials.gov as an endpoint. When the trial was designed, nobody knew that immunotherapies can cause pseudoprogression (and VEGF inhibitors can do the opposite - make it look like there is no progression when there actually is progression!) and make it hard to determine when progression occurs. PFS is used because it is faster to achieve than overall survival, but overall survival is way more important. PFS would have led to Accelerated Approval, but Overall survival should lead to a full approval. In this case, the PFS difference was not statistically significant - probably because especially in the early case before they knew about pseudoprogression, they thought that the changes on MRI were progression and called it progression when in reality it was not true progression.
                By telling the FDA which endpoints they are going to use before they unblind, it prevents the FDA from dismissing them as a "fishing expedition". The trial for ICT-107 had that problem - they had great results in certain subgroups but those groups were not predefined, so the FDA required another trial - which the company couldn't afford so they stopped development. That will not happen in this case because the FDA was notified in time.
                I can not comment about SEC stuff.

                Comment


                • andromeda_m31
                  andromeda_m31 commented
                  Editing a comment
                  Yes, I understand that. But why has NWBO not updated clinicaltrials.gov to reflect new endpoints? It means FDA has not accepted them? This update is the only thing stopping NWBO stock price from being at $20 by now. management keeps crying over naked short selling, but does not want to update clinicaltrials.gov. Why? Neither does the management communicate with shareholders? What kind of a publicly trading company is this?

              • #9
                I know nothing of the politics involved. I doubt if the clinicaltrials.gov listing is affecting the stock price.

                Comment


                • Henrik
                  Henrik commented
                  Editing a comment
                  I think there is too much talk about stock prices... good for the people that want to make money on the progress but it sort of isn't the point of this news...

              • #10
                Agreed completely. I will avoid talk of the financial stuff. There is enough of that elsewhere. Let’s focus on enjoying the win of a new option for brain tumor treatments. ( and possibly all solid tumors).
                We just have to be careful of what we read and info we spread. There are bad people out there that place money over health. They distort the truth so they can make money. Always consider the source of the info you get. Start with the original presentation.

                Comment


                • #11
                  I am open to opposing viewpoints or questioning data. That is healthy and allows us to learn. What I do not like and won’t tolerate is the attempt to twist the truth for financial gain.
                  Looking back this same thing happened with most treatments approved for gbms. I thought they were honest differences of opinion that I tried to correct. I felt like I was banging my head against the wall and couldn’t get people to understand the truth. But now looking back I see the motivation and it had nothing to do with the truth.
                  The only way to avoid this is to keep the next treatments out of the stock market. I am working on ways to make it possible for small private companies or even charities like mine to develop new treatments all the way through fda approval.

                  Comment


                  • andromeda_m31
                    andromeda_m31 commented
                    Editing a comment
                    I agree with your thoughts. But NWBO not updating the clinicaltrials.gov website with the new endpoints, gives a valid reason for the nefarious actors to kill the company and its drugs. Regardless of how breathtaking this data is, the fact remains that PFS performed worse than SOC and PFS is still "officially" the primary endpoint (until NWBO updates clinicaltrials.gov website). People like me who are small shareholders have no clout with NWBO management and they have actually blocked us from sending them emails. So I request you to ask NWBO what is going on? Why don't they update the website if FDA has allowed for endpoint switch? These are valid questions, so why is NWBO not doing the right thing? Linda Liau has done her part to perfection. Why can't NWBO management do the same? What is their problem? This misery of market rejecting this groundbreaking study data, is of NWBO's own making. All problems can be solved by one little update on the clinicaltrials.gov website. Cheers.

                • #12
                  DCVax-L analysis is done w.r.t ECA. If I were a reviewer of phase-3 manuscript, I would ask Linda Liau et al to also show survival curves for DCVax-L w.r.t the internal control arm (placebo). I know that 90% patients got DCVax-L due to crossover design. But there are 30-odd patients that only received SOC. I know this is not enough data to have reliable survival curves, but nevertheless, for the sake of science, DCVax-L vs placebo curves are a must. Otherwise, it is just bad science. No respectable reviewer can let this manuscript get published without this crucial survival curves included in the paper.

                  Comment


                  • #13
                    That might be true if the small group of patients who did not get dcvax were selected randomly but in this case they were not. The only people who did not get dcvax either progressed so quickly that it wasn't worth trying dcvax, or they did so well that they did not need it. It is not even worth looking at those numbers as they are meaningless.

                    Comment


                    • andromeda_m31
                      andromeda_m31 commented
                      Editing a comment
                      You may be right. But that is not how unbiased science is done. Nobody gets to decide what is meaningful or not. Those plots must be published for the sake of "completeness". All the caveats you mentioned, can be mentioned next to the plots. Papers are not just to show the pretty plots. And I say this as a scientist myself with publications in the most prestigious journals, some of my work having been featured on top news channels.

                  • #14
                    I have not seen the publication yet so I do not know what is in it. I do know they will have a booth at ASCO where you can talk to the researchers and ask that question. Are you going to ASCO this year?

                    Comment


                    • andromeda_m31
                      andromeda_m31 commented
                      Editing a comment
                      Can you please ask aacr to correct this nonsense on NWBO. Are they scientists or idiots? This almost looks deliberate. Are they colluding with short sellers? https://aacrjournals.org/cdnews

                  • #15
                    I already wrote to them yesterday! I do not think they are colluding. I think a lazy editor saw some of the fake news and reprinted it. It would help if a LOT of people wrote to [email protected] and asked.

                    Comment


                    • andromeda_m31
                      andromeda_m31 commented
                      Editing a comment
                      Thanks. The number of market makers for Northwest is usually about 6, but on May 10th, there were 13 market makers; more market makers facilitates shorting. There were 77 million shares traded on May 10th and I believe that based on past experience that 80% could have been counterfeit shares (created through naked shorting). A drug can not come to patients if the company does not survive. So, what are you, the advocacy groups, the company, the scientists, the big investors doing to bring the perpetrators to justice? Similar thing as happened in the past (2015 when the stock lost 95% value). Where are the libel and criminal lawsuits? These low-lives have killed millions of patients across all diseases, year after year after year. What are you all doing to inform DoJ and FBI about this?
                  Working...
                  X