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And yet we have not received a PR about an MAA submission. So not sure why it matters that theoretically they could be submitted in parallel.
The logic is this is an investment. People put their money here because they expect to make money. You can’t expect people to stay invested in anything for years if their investment doesn’t grow, regardless of any milestones met. I have been invested since 2012 and have been very patient. Patience is beyond wearing thin. I want to see some return, yesterday.
Double dosing of what? I thought DCVAX doesn’t work? It means nothing how many doses they got since they are compared with external placebos. You fail to understand that your argument of double dosing doesn’t change the fact that scabs works as compared to placebo, the dose does not matter.
I wish my great great great great …. great grandfather had bought the first share of the wheel, we would have had generational money by now. Oh well, I guess he didn’t have a Time Machine at his disposal.
Nonsense
Why? Just because you want it to?
They did which was decided by the independent expert panel that formed the external placebo group.
Isn’t 16% 3x of 5%? How much does Avastin impact OS at 5 years? Yup, zero or worse, negatively. What side effects does dcvax have? Yup none. So risk benefit analysis is???
In a journal as prestigious as jama? Why didn’t they submit their editorial to jama? Oh wait, they did and it was rejected. Why did they not disclose their COI with a chief competitor? Speaking of which, who pays your bills?
Wrong. Journal editors and reviewers are very cautious with the wording they allow in trial manuscripts. The fact that this trail was published with such strong language means that the trial methodology and statistical analysis passed the inspection of Jama’s standards. There is simply nothing you can say that will change this simple fact.
Every neuro oncologist and radiation oncologist I work with is skeptical of the Optune data, and that’s after watching it “work” in their patients in real time.
Remind hygro, since you’re such a stickler for proper trial methodology, was the optune trial a double blinded placebo controlled study?
And it was still approved? Interesting.
Failed studies that are published don’t have titles and conclusions that they succeeded. You should read this manuscript again and focus on the conclusion. It’s pretty black and white.
Second dose of grapefruit juice should have helped patients with a lethal disease. So which is it? Does dcvax work or not according to your expert (lol) opinion?
Why unnerving?
Dude, the word checkmate doesn’t even make sense in this context. I think you need a different verb. At the very least try to switch it up a bit.
rr
Someone has a lot of time on their hand ;)
So what you are saying is that dcvax worked better in recurrent GBM than nGBM? Placebos who crossed over had greater OS than patients initially treated with DCVAx?
Correct. Also note it is not in jama. Jama would never publish it.
There will definitely be a rebuttal to this rebuttal as this “paper” basically calls into question the methodology of the Lia by calling them out for using the term “prospective”. This is an outrageous accusation, “the investigators had seen the data… and then decided to go ahead with the cross trial comparison”.
Clearly this cannot be true as this would be a major violation of academic integrity. Furthermore, there is zero chance a journal like Jama would allow the original paper to be published as is if this were the case.
My birthday was the 19th. I was so excited when I saw the “manufacturing approval”…
Thanks. So assuming nice makes the recommendation that dcvax become part of soc (sounds like this could take a while?). Does this influence mhra decision or is this a separate parallel tract that can influence but is technically neither necessary nor sufficient?
Are you serious? I’ve long since before you ever heard of this company.
Thanks for the response to a genuine question genius.
The question is SP performance at what point in time? If the sp goes to 50 tomorrow we would all agree that they deserve it. If it goes to 0, the opposite. It is a little unfair to assess only in real time. But I agree that there should be some element of real-time performance.
I don’t understand how Nice would decide on the validity of the efficacy before the mhra. Seems backwards. Can some explain?
Thanks
RR
Thankfully we are no longer in the dark ages in terms of immunotherapy and there is broad acceptance of pseudoprogression. Therefore this comparison is meaningless. The evidence to support this has been posted numerous times. The only people who will not accept this data are shorts (ehem) and purists. It matters not. There will be no new trial. Dcvax will be approved based on the phase 3 trial that has been completed.
There is zero chance this will not be approved.
Iron Mike nails it again (retrospectively of course)!
Nice one man
The issue is not that they can’t get a JV now. The issue is that at this price it would mean us losing out on major future value. That must be their calculation. Optimise MC before partnership or BO.
And you really believe that the jama editorial board and review process has no clue about “the oldest play in the book”??
Come on man. This notion is ridiculous
And if they have been doing more it’s their job to inform us, not our job to speculate all day long.
And therefore your answer is?
You can’t really cite data from an abstract in a paper. The final jama paper just came out so they could not have cited it when this paper was written. This is standard research publication stuff. Happens all the time. By the time something is actually published it may be outdated.
It’s not fair to compare Moderna to Nwbo. It’s David and Goliath. That’s why this is an asymmetric investment.
According to jama it was a successful trial.
Make up your mind
Agreed. I didn’t even ask ;)
I spoke with him yesterday for 45 minutes. Was a good chat. Obviously nothing new to report.
You did
Lucky for us and patients you are not in charge of the FDA.
See you after approval
So it has an effect and helps patients with probably the most lethal form of cancer but you are in favor of scrubbing this treatment because of a somewhat convoluted trial, largely due to circumstances outside of anyone’s control and with a reasonable charted path forward towards approval?