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OS with an RCT is the gold standard not changing the trial after failing the first protocol and using unmatched ECA years after the last patient was treated.
If it had “”known positive results” they wouldn’t have changed the endpoints and they would have submitted a BLA to the FDA 3 years ago. Instead they submit the garbage they did to the MHRA with an unmatched ECA because the FDA is explicit about defining the ECA prior to running the trial. The MHRA will reject it for the same reason even though they don’t have that requirement in writing. It’s all to buy time and kick the can down the road while Advent builds its business so LP can sell it while laughing to the bank.
Perhaps she wants something that works.
I guess you haven’t seen the oncologists who are not involved in this scam trial, who have commented on the external control arm being bullshit. Not to mention the FDA requirement of defining the external control arm before you run the trial.
“It also isn’t proven to increase long term survival in GBM patients.”
It would be if they compared it to some bullshit, external control arm.
Yes legitimate companies admit when they did not hit their endpoint and end the trial, not change the endpoints and throw a Hail Mary in the UK.
The company has no combo trials near a P3 and no money to run one.
Or have better odds and go buy a Mega Millions ticket.
100 years from now flipper will still be talking about shipping labels and job openings and the company will still be blaming Covid for never having anything approved.
This biotech will always be pre-revenue while LP has pocketed a few hundred million for an expensive placebo.
You have no idea. LP said numerous times that they had money to get this to the finish line AND advance Direct (to more trials showing it does nothing). This after she fleeced Woodford for $95 million and fleeced shareholders by building 2 CDMOs while they got zero benefit.
If you understood the basics of a shady penny stock you would’ve put your money in an index fund or AAPL and would have actual gains instead of your red paper in your .50 stock.
The post to which you are referring has nothing to do with Direct. True, neither one work, but this is specifically regarding the tiny L trial with very few GBM patients, only 6% (one patient) reaching 60 months. If anything, this just highlights that the P3 uses the least effective treatment which is why they didn't compare it to an actual control arm.
If we are digging up old trials, might as well regurgitate the long term survival of the early ICT-107 trial :
Only one GBM patient in the Poly-ICIC arm lived over 4 years. None of the other 4 lived over 29 months.
The longest living GBM patient between the placebo arm and the Poly-ICIC was in the placebo arm. The only one who lived over 5 years.
So this trial shows the following:
Only one of the 15 GBM patients in this trial lived over 5 years. Therefore the 5 year OS expectancy of a GBM patient receiving DCVax is 1/15 = 6%. About what is expected from SOC.
Thanks UCLA for proving your own treatment doesn't work. See what we can conclude from following breadcrumbs?
Polaroid has a bunch of useless patents too.
Be careful. After they change Cofer’s Depends, he’s coming after you!
Glad that Hoffman and Dr. Blabla paid pumping have been exposed.
It's a 21 patient open label P1 safety trial with secondary efficacy endpoints. When the first 3 enrolled patients show promise it's something to write home about.
And they were treated last year, not in 2012 when the DCVax trials first patients were treated. Let me know how DCVax's first 3 patients fared.
Every patient in the trial went through chemo so I’m not sure why you think the company’s inability to run a credible trial has anything to do with having chemo or not.
And F anyone who thinks this company gives a shit about cancer patients. If they did they would have tried to get it approved via EMA or FDA. And it Wouldn’t be three years after fucking datalock for them to submit anything. The lowest of the low is LP profiting off the back of cancer patients while building a couple CDMOs off the backs of shareholders.
Your oncologist has never heard of DC VAX because it’s useless. Nobody has except the shills here who learned about it from some penny stock blogger on Twitter 15 years ago. Nobody is helping cancer patients by funding LP’s retirement. Anyone wants to help cancer patients they can donate to their local hospice.
It’s the same in that doesn’t work for either indication.
I'm absolutely clear on the process. As is the company. And they haven't done shit.
Let me know IF you actually read this.
https://www.fda.gov/media/82647/download
We aren't talking about making a generic aspirin. It's a biologic. An expensive one that they haven't even show to work. It will require a "totality-of-the-evidence" approach.
It's blatantly clear you are another idiot buried by confirmation bias.
You do realize that showing comparability of a personalized biologic made from ones own tumor would require a human, yes?
Bullshit. Feel free to screen cap your holdings and cost basis. It hasn't been much cheaper than the current price since you've been running your crap little website and babbling about nothing for the last 3 years. But it's certainly been well over $1 for much of that period of time. I'm sure you didn't buy any of those cheapies.
Not to mention you can't "beat dilution" by never selling. So you've actually sold? No, you don't even own shares.
We really need to narrow down who makes the expensive placebo!
Sure. And the bogeyman lives under your bed.
LOL. What have you offered but diarrhea of the keyboard?
Serious investors like dbag Hoffman and DD? OK. And yet none of those long term survivors have a phone or Twitter.
Kinda like parading Brad Silver out 100 times like that proves it works.
Or the company stating "we have all these compassionate use cases that are doing great" yet never revealing any of them and none of them stepping forward. Let me guess, everyone else signed an NDA to NOT say how great they are doing.
Longs: "There was so much demand we had to shut it down and let Advent handle both patients!"
She's the record executive who fleeced the rockstar.
5% of the compassionate use cases have done great, just like 5% of the GBM population. If only they could run a trial with a legit control arm, they could prove it does something. They failed at that.
This board has been hyping imaginary Specials revenue for years now. And nothing.
Nobody cares about future trials. It took them 13 years to report on a tiny P1 combo trial from 2010.
Once L is rejected the company is dead. LP will have already sold Advent by then.
Another day further in denial.
It's a Doc Logic post. As verifiable as unicorn farts.
The next step is resubmitting everything indicating that they no longer are using an RCT which is referenced in all the documents. And then the experts can comment in the matrix what a trainwreck this new trial is and the submission can sit there with no movement for another 5 years waiting for a response from the company while LP puts the finishing touches on Advent on NWBO shareholders dime and sells it.
Hope doesn’t treat cancer, an approved treatment does.
If the company gave a shit about cancer patients they would have started over in 2015 when the DSMB told them DCvaxt didn’t do shit. Or if they actually believed this worked they wouldn’t have pulled their pud for 3 years after data lock to submit to a tiny market like the UK.
What was the SP and how has your investment worked out so far?
Now recount the times every year you said this would be over $5 or over $10 a share.
Now recount how many times “big news” was happening at ASCO despite them not presenting at the big boys table?
Let’s go over every time you “believed, hopes, or wished” something that never happened.
Obviously, the White House signed an NDA