Are you throwing me a softball on purpose? Everything so far has gone in the longs favor (TLD, revised endpoints, lawsuits, patents, friendlies, covid vaccine profits opening the opportunity for a buyout). The patients were stratified for MGMT methylation so that there would be an even distribution among both arms. This is important because it is not like MGMT methylation came out of nowhere. They've been speaking about it forever. Dr. Bosch has spoken previously on the delta between MGMT methylated and unmethylated patients and years ago said it is possible at that time it is due to treatment effect of DCVAX.
Why would FDA approve DCVAX broadly across all GBM if it is shown to not work for unmethylated patients? Why would the regulators not extend the biomarker approval outside of glioblastoma? At the current rate of progress and what is underway right now for clinical trials, it would be a miracle to see 5 blockbuster drugs approved in my lifetime (and I'm very young). That is absolutely pathetic given the state of science. The outlook is horrific if you include public market mechanics. People like you are why Liau's birth country can become a hotbed for war once her life's work is approved. I told you the outlook is horrific. The American markets gave birth to the hell rift.
What a great decision for the FDA to oversee. Approve a therapy for GBM and maybe start a war in Taiwan. You think it's unrelated, but it's true somewhere. That would be shortselling's fault. The SEC and FDA should have coordinated much better at NWBO front. They let the pressure build on this timebomb. How do you think the world will react if they let the company continue blinded and attract the investment dollars for years, just to turn down the approval? The Americans look pathetic across the board (Army, FDA, SEC). The FDA can save their reputation and give NWBO a biomarker approval irrespective of tumor location. That ACTUALLY stimulates the economy and helps the most patients. It arguably creates the most jobs. What are they waiting for? The FDA is not supposed to make financial decisions, so they'd start a war without even realizing what they did. I don't think anyone can complain for as long as I can about that side of things.
Another reason the outlook is horrific is because the whole industry made them build their own automated cell incubators, only to likely buy the company out after they solve all the hurdles on their own. That is as [retarded]x2 as it gets.
You make it sound like the FDA would approve the therapy in the wrong way and have it dispensed to the wrong patients where it won't work, while also not approving for a biomarker, something they have done just recently for the first time.
It's as if you would like them to not look at the data or look for where the treatment is having a positive impact on survival. That's the whole point of continuing the trial many years ago and not unblinding too early. What about the long narrative on the clinical side has not come true? Only the hypothesis on gross total resection being necessary. Liau knows her field. A lot of people have made money on her work and will make more soon.
The journal article will come out and confirm that extended survival is tied to the flares on MRI. I also don't believe everyone on the treatment arm that receives DCVAX will flare on the MRI. That should be a very clear signal for people like you who burst into the NWBO forum like a cowboy needing a tavern.
They say not to feed the bears, but the discovery is that they're [fed bots]x2...
The whole world is looking at the YANKees wondering when they'll get their first compass. Flying porter is just that easy. Get it Yankee? That's your soul coin going through the wormhole...
1 post a day tell the mods I need a raise