Sunday, August 29, 2021 7:38:42 AM
Certainly glad I didn't miss this insight.
and furthermore
Perhaps you missed the journal article released on the still blinded data. Not sure why I am taking the time to educate you and help you but feeling generous and gregarious this morning.
What we already know is that some relatively large portion of the GBM (GlioBlastomaMalform) patients are effectively cured by DCVAX-L. This is the long survival tail you will read about, but there are challenges proving this with the original end points.
The original end points are still there but there were issues with Progression Free Survival because we now know immunotherapies can cause tumors to enlarge initially as the immune system attacks the cancer cells. That can be misinterpreted as progression. Most of the 331 patients have received DCVAX at some point in the trial so comparing median or overall survival to a placebo group may be problematic. They still may meet the original endpoints, but the good news is that we know from updates to the European website's and other sources that the primary end point has change to compare DCVAX treated patients to recent historical SOC for GBM overall survival and since the SAP is the same for all the regulatory agencies we know that this will be the case with the FDA too. We know of the still blinded data the DVAX-L that was published in a journal that it will blow away recent historical SOC.
So relative to recent historical SOC we know that top line results will be extremely positive, at least this good from the still blinded data on all 331 patients
https://nwbio.com/updated-interim-data-from-phase-3-trial-of-dcvax-l-for-glioblastoma/
The historical GBM SOC survival
https://www.nature.com/articles/s41598-020-68011-4#:~:text=%25%2C%20respectively36.-,Discussion,glioblastoma%20during%20or%20after%202005.
It is clear from the still blinded data that DCVAX works in some of the people some of the time (a good number of patients).
Trial will not fail unless the powerful big-money thugs are able to rig the game.
If this is played fair and straight approval is a slam dunk.
SOC it pretty much a death sentence (4% survival at 5 years).
With DCVAX 1 or of every 3 or 4 are effectively cured and about half are cured if they in the methylated subgroup.
Also since DCVAX has orphan drug status
From the recent press released there seems to be a lot of focus on their volume manufacturing, getting it approved and up and running prior to DCVAX-L approval.
You may scratch your head and wonder why if the data we already know is this good why isn't everyone is raving about DCVAX as a miracle treatment. There are big money thugs working to try to take NWBO down, bankrupt them and steal the technology for a long time.
There has been speculation that there are hundreds of millions of naked short shares too that they had assumed they would never have to honor if the company went under. These naked short NWBO shares that still needs to be covered when the stock price skyrockets after results are announced and approval. These thugs succeeded in driving the stock price from a high of $12 to 14 cents and forcing the company off of the NASDAQ through carefully manufactured disinformation (e.g. Phase-5 Report) and then dozens of frivolous highly-publicized law suits. It appears that even now as we are sitting on the 1 yard line anticipating approval soon these goons still believe they can prevent approval and steal the technology. They have shown that they are extremely clever ruthless people that obviously have not given up yet so I am glad Linda has not let her guard down and is playing this close to the vest. Lets hope and pray for GBM patients she is successful.
I don't know how they still plan to stop NWBO and DCVAX, but they clearly have something they believe they can gain even now or we wouldn't see them still so involved. We watched them drive the price down to just above $1 back in April. It quickly recovered but supposedly this was a bear raid to trigger automatic stop loss sales and pick up some cheep shares theoretically to cover some of the naked shorts. We have seen this happen multiple time.
GLTU
Men who are occupied in the restoration of health to other men, by the joint exertion of skill and humanity, are above all the great of the earth. They even partake of divinity, since to preserve and renew is almost as noble as to create.
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