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Wednesday, August 18, 2021 7:07:11 PM
Published eye-poppingly great still blinded trial data that conclusively demonstrates that relative to recent historical SOC 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/
Survival at 3 years is 28.2%
Survival at 3 years for 41.1% (methylated)
The historical GBM SOC survival
https://www.nature.com/articles/s41598-020-68011-4#:~:text=%25%2C%20respectively36.-,Discussion,glioblastoma%20during%20or%20after%202005.
3-year survival was 11%,
and 5-year survival was 4%
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).
We learned more recently that the succeeded in changing the primary end point 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.
And they have completed the trial - DATA LOCK Oct 2020.
So they may have been on the verge of bankruptcy for years . . . but not sitting on their thumb by any measure.
and now we wait for a journal article, TLD and approval and stock price well over $10 a share despite the dilution you mention necessary to keep the lights on and the trial moving forward unfortuantely.
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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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