DCVAX Approval for MGMT Methylated Tumors Irrespective of Tumor Location
That's a huge market (way more than $10B) and even pediatric glioblastoma can be MGMT methylated. I looked this up because they filed for Pediatric Investigation Plan and that seemed counterintuitive based on the results of our trial showing that elderly performed better. It is possible that they are opening up their capabilities to pediatrics specifically for MGMT status.
For anyone new reading the board..
Methylation is an epigenetic modification that silences the expression of the MGMT DNA repair enzyme which gives patients a better prognosis with chemotherapy because the tumor does not repair the damage. However, it does not explain the increased survival that we see when we compare it to unmethylated patients in this trial.
If you take patients matched for prognostic factors like age, extent of resection, and methylation status, you will see that the patients who received DCVAX AND were MGMT methylated survived longer than patients who were MGMT methylated, but did not receive DCVAX. This comparison is being done with external control patients from the same time period as our trial was run (contemporaneous), what doctors worldwide consider best practice for the statistical analysis of this particular trial.
We should have had this approval years ago based on blinded data showing that the patients who were MGMT methylated had a survival curve that separates more than usual from the unmethylated counterpart. Strangely, it seems that the FDA has to solve the financial side of things by delaying the development of therapies and hoping that people sell from the fear that it's taking too long.
If they don't act in this capacity for their flag, they snub their own noses twice over.
1) They allow money to exit the country because the Market Makers shortselling lose from their early decision.
2) Cancer therapeutics approved in an expedited way in the USA only serves to increase longevity to the point that they are outpacing other countries, the result is more social security paid out.
Now you can officially tell the FDA that if they make financial decisions they are negligent to the patients and long shareholders. If they don't make financial decisions they might lose their flag and therefore are negligent again.
If the Real Time Oncology Review was worth its name approval would've happened early.
You should consider that with the pervasiveness of cellphones, everyone enrolled into the DCVAX trial who even speaks in front of their cellphone to their family members about their participation in the trial will provide a dataset to companies like GooG, and others. They could perform a contemporaneous comparison themselves before the data is even out just by listening to the things that are said.
Example: Person says they have inflammation at the injection site and therefore probably received the active DCVAX. Any other time they tell their family about how they feel, mild side effects reported etc.,, it is added to the database. If you capture enough of these unique individuals and Apple provides Iphone data with GooG through a backdoor trade, they probably have all 331 patients and their stories. I'm sure they would tell their mom, dad, or kids "I got the MGMT methylation so that is a good sign."
or... "I don't have MGMT methylation and the doctor said that it doesn't help my situation"
or... "The doctor said they got a full resection"
or... "The doctor said they could only get most of it, but they took as much as they could."
At that point the AI can perform a blinded review of the data as a whole and compare it to contemporaneous patients with matched prognostic factors and GooG initiates a long position.
Maybe this is why our stock has stability at 60 cents? I'd say so.
Cuz otherwise it would be zero... OH SNAP!! VERY LONG NWBO
Only 1 Perfect Come Through Wormhole,
Goo-G's Casted Soleilmana,
The Electric Escape.
AI
