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Okay so your example is a bit incorrect.
"/3 are on SOC and most all event within 1 month. While 1/3 get a magic cure and live for 10 years. The median is under 1 month."
The median isn't necessarily under 1 month. Its the middle most point, its the survival of the patient at the exact halfway mark.
So if 49 patients live 1 month, and 49 patients live 5 years, and one patient lives 1.1 months, then the mOS is 1.1.
And yes, my values are not weighted average of the two median distributions.
If you add 1 month to every single patients in the example above, the median OS would be 2.1 months
Have you read the blinded data report? It's 331 patients at a 2:1 ratio, meaning there were 221 DCvax-L treated and 110 placebo arm. Also, the secondary outcome for the study is an mOS that is 2 months greater than the placebo arm. Does that make sense???
Yeah I don’t know where he gets the 14% as it is not in the report nor in the presentation. What is in the presentation is 100 patients saw mOS of ~58 months. Even if it was in the presentation the graph shows 60 more in the 14%to 15% range
What mystery mode? It is explained in the article. It is just mathematics and statistics. We understand the ratio, it’s 2:1 treated to placebo.
So if you know the SOC graph you can then adjust the data to see what would be needed for the same blinded results.
Take the equation a + 2b = c. If you now c (blinded data) and you can plug in a from other SOC trials, then you can solve for b.
For the unsuccessful model it is trial and error, as we are saying the mOS of a is < 2 months. So I keep solving for both until I get the same blinded results. Hope that helps.
ExWannabe, what kind of statistical knowledge do you have? LOL
1) The first chart compares Optune's data if it were unblinded, with DCVax-L. unblinded data which greatly outperforms it. NOT SURE HOW THAT ISNT SELF EXPLANATORY???
2) Not sure you understand the difference between mean and median. The average (or mean) time between randomization and surgery was 3.1 months for DCVax-L. So yes, some of those points may be +/- 1% or less, however, that wouldn't adjust the graph too much, as you would still see an mOS ~ 20 months, sure it could be 20.02 months, or maybe 19.98 months. Not sure why you would focus on such an insignificant component.
3)Wow, were do you get your numbers from. The top 100 patients had an overall survival of 58.4 months. Thats where you get that number from.
4) The first year is the only improvement? Are you comparing it to the SOC, or Optune's treated arm? The point is that the blinded data is better than Optune's treate arm, let alone blows the SOC out of the water. LOL
The focus on median means I understand clinical trials and statistics. It doesnt matter if you reach statistical significance, if you can not meet the median OS endpoints which in this case is > 2 months. What the article is showing is that even if it doesnt meet this > 2 months, both arms are so much better than SOC and since its a crossover, then it must be the vaccine.
WOW! I cant believe I have to explain this to you!
Ha ha!!! Rintega ?? Really??? LOL
Rintega was targeted to a subset of GBM population that has the EGFRvIII mutation which only occurs in 1/3 of patients!!!
Talk about a more selective criteria! This wouldn’t even or shouldn’t even come into the conversation regarding a DCVax-L comparator.
You are grasping at straws my friend by suggesting this and you are also shooting that you don’t do your homework. You are blindly trying t throw mud at the wall to see if it will stick! LOL!!!
I had a good laugh! Thanks iclight and exwannabe!
GREAT ARGUMENT EX!!! LOL
Also. I don’t believe any of those were trials for GBM. Show the links with mOS.
And it sounds like Sunrise and Bavituximab are the same thing! LOL
Please enlighten us with the mOS of those trials.
Bavituximab achieved 18 months while using Optune devices
Show me one of those studies that achieved blinded results greater than 19 months????
Oh right! Please enlighten me with the results of failed trials? Hmmm maybe you can list ICT-107’s phase 2 trial (
They had an SOC mOS over 16 months with treated arm at just over 18 months. The blinded data is showing 20 months. 4 months better than SOC and 2 better than Treated. And that trial failed.
Then sell. I have not had many dud recommendations. One I think. I recall all the shorts yelling at me that Lululemon was a fad and I kept buying it from the $30 IPO down to $4 a share. And look at it now.
I recommended Netflix when it was down less than $50 a share and prior to the 3 for 2 split. Shorts said it was over valued.
I mean if you don’t want the risk then you won’t get the reward...
Lol!! How can the best blinded data be a failure. I hope there is another dilution so more shorts get pulled in. After reading that new SA article there isn’t a negative scenario with the blinded data. So I welcome more shorts like you exwannabe! Keep the short movement going! It will be a sweet squeeze when all said and done!!
Would absolutely love seeing the shorts get burned! And yes, I think the price will jump spectacularly if it gets squeezed!
Makes sense why the quietness. The Calm before the storm!!!
Interesting that you have a window into management's confidence. Funny how they just hired significant additions to the management team in the last year. That spells to me there is alot of confidence there.
I disagree. The fact the article models what an unsuccessful trial would be which shows the SOC nearly as good at Optune’s treated arm. That tells me that this is a successful trial.
My market cap comment had nothing to do with the article. It was my opinion if results of trial are positive.
Wow! Sharp as a bag of hammers!!
I disagree. Not pumping as I haven’t said anything about it, if it’s positive or negative. Funny how everyone just jumps on these speculations! Lol!!!
I am saying that it should be. With the FDA’s new guidance. The blinded data is better than any trial out there and considerably better than SOC. So yeah I believe it is worth $10B. The reason I believe it is at $0.20 a share is that NWBO isn’t willing to be bought out by Big Pharma, so they have but millions shorting it.
I disagree. Sometimes the right information is all you need!
Yes, but it is what's in the article that is most compelling!
NWBO is worth more than $10B at this point, with the blinded results. It's probably closer to $20B IMHO
Have been messaged that an article is due out tomorrow morning on NWBO. Exciting!!
Ahh. I don't moderate anymore. Will have to sign up again.
How do you add a post as a sticky? Would like to add the Blinded Data graph to sticky posts.
Actually AVII77, I adjusted it so they are both on time from randomization. Hence the mOS of DCVax-L is at ~20 months not 23.1 months! LOL! Nice try
How do you post that graph the to top permanent posts?
Except your graph isnt to scale, you can see that easily, even if you take into account the 3 months from surgery to randomization. Its not to scale, and therefore shows it to be worse. I actually graphed these as well as Optune's Blinded data which DCVax-L greatly out performs! LOL!!
How do I post a graph/pic of Blinded DCVax-L data vs. Blinded Optune and Optune SOC data on here? Does it have to be a link to an already posted graph?
Also, how do you add it to the top post that are not removed?
I read that article you link to in Medscape. It argues that quality of life should be one of the trial indicators and that PFS can be manipulated more often and say OS should be one oft he endpoints. Also this is of trials done in Europe so a little misleading to characterize this with Optune and DCVaxL
I linked it in one of my previous posts!
What does compliance rate matter? It was a blinded trial that showed 2/3 of the patients outliving the other 1/3. No matter if some used the head set more than others. It means it could’ve been better results had the patients used the headsets.
No matter your argument, the Optine trial was a success and it didn’t do as well as the blinded DCVax data!!
Oh no!! I’d wait for that to sell my stock for $100 a share in December 2020
They do show that patients that logged using the device more often showed better results. Is that what you are trying to say?
Progression free survival and overall survival are two different things. ?? Don’t quite understand your thought process.
Trial started in 2009 and completed in March 2017.
https://clinicaltrials.gov/ct2/show/NCT00916409
Where do you get your information from? Stopped collecting after 24 months. LOL!!
Look up the published report on the trial. It was also done by Stupp, who was part of the original 2005 Temozolomide trial that became the SOC.
Original Stupp 2005 Trial Report:
https://www.ncbi.nlm.nih.gov/pubmed/15758009
Optune Stupp Report:
https://www.ncbi.nlm.nih.gov/pubmed/29260225
ALSO look at the publication, they have data up to 5 years (60 months).
This policy would benefit all of Big Pharma, so am not certain they will fight it. They dont fight policy where they are loosening the regulations, but rather tighting.
If you look at the Optune trial data, methylated patients saw an increase in mOS of 10 months.
Optune mOS methylated: 31.6 months
SOC mOS methylated: 21.2 months
So not sure how this subset of "methylated" patients would increase the overall methylated mOS.
Oh and btw, DCVax-L's blinded methylated results:
Blinded DCVax-L: 31.7 months
And their unmethylated data didnt seem to help much increasing less than 2 months:
Optune mOS unmethylated: 16.9 months
SOC mOS unmethylated: 14.7 months
Blinded DCVax-L unmethylated: 16.9 months
REMEMBER! DCVax-L is blinded results, therefore the treated results will be greater than 16.9 months!!!
DCVax-L vs. Recent Historical SOC Newly Diagnosed GBM Trials (all mOS from randomization)
ICT-107 P2 SOC: mOS = 16.7 months
ICT-107 P2 Treated: mOS = 18.6 months
Optune P3 SOC P3: mOS 15.6 months
Optune P3 Treated: mOS = 20.5 months
https://www.optune.com/clinical-study-results
Blinded DCVax-L: mOS = 20.9 months
DCVax-L's blinded results outweighs any of the latest results.
This is the document about using SOC for crossover trials:
https://www.fda.gov/media/133660/download
Having the capacity and actually producing are two different things. You should know that!