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who said this? source?
yeah maybe stop lending them out?
source?
5% is way off. 99% is of course too high but with everything we know in progress and the data we’ve seen, 5% is a joke
why so angry at this statement? not trying to be condescending, actually curious
agreed. i expect mid-sept for submission acceptance. Nov/Dec approval?
also there was this, which has pediatric study plan on the checklist
$NWBO
— hoffmann6383 (@hoffmann6383) July 6, 2022
Are we at the 3rd (and final) part of the Real Time Oncology Review submission package with the FDA?
fyi - RTOR states you can't PR that you are within the program until the complete BLA is submitted. This would be consistent with today's language in NWBO's PR. pic.twitter.com/ePXzzVhelp
i think it’s being kept down a bit because of the C shares. if you own 1M common shares and see the price at .70, why not sell all your shares and rebuy them as C shares at .62? if there’s a clause or something that someone knows about that prevents this please share
what you seem to not be grasping is that the term “endpoint” encapsulates both comparators. if an endpoint is comparing group A to group B, and group B is confounded, the endpoint that compares those groups is confounded. but group A and its data still exists and can be compared to another group C.
again it seems like you’re just throwing these words together without understanding what you’re talking about. gibberish. it’s okay, this is complex stuff, but you’re diving into an area you seem to know nothing about and making weird nonsense claims. it’s hard to refute what you’ve said because what you said isn’t even coherent. the original OS comparison between ITT and placebo was confounded by crossover. the new OS comparison to an ECA fixed this. NWBO admits the original OS endpoint was confounded, which is why they changed to using an ECA. nowhere does NWBO state their new OS endpoint is confounded, that doesn’t even make sense.
curious why you think the article was submitted around March 2022—I thought general consensus was about a year prior to that. thanks.
The original endpoints were confounded. The original OS endpoint compared to in-trial placebo, and was confounded due to crossover.
The NEW endpoints, changed before datalock, are NOT confounded. The new OS endpoint compares to an ECA, which crossover does not confound.
There are concerns with NWBio, but this is not one of them. There’s nothing else to say—if you don’t understand this by now then maybe you won’t ever and that’s fine, don’t invest.
dude, the endpoints in the SAP are not confounded. idk how you don’t get this
the old endpoints were confounded. the new ones are not. i’m not sure what you’re saying, and not sure you’re sure what you’re saying
most negative folks on here are shareholders who are highly anxious and use this board as an outlet for their anxiety. then there are those who have no idea what they’re talking about (hygro). very few bears bring up legit concerns.
meanwhile, nwbio is plodding along—extremely and agonizingly slowly—checking off tasks and inching forward. i get why people are anxious and impatient, but the tortoise does finish the race.
and yet, global deaths from covid are 15x+ that of gbm per year, likely much higher without vaccine. makes no sense to compare vaccine approval between the two.
the (big) thing you’re ignoring is that covid is contagious—gbm is not contagious
? what did i say that angered you. you’ve made a lot of assumptions in your response to me (for one, that i’m even a guy)
it seems about half this board has heard it at this point. why not release it? making it public could only spell bad news for AF and STAT
I mean, you could just call and see for yourself. Or just keep coming up with conspiracy theories and avoid seeking out info, whatever
Ex, a lot of the “issues” you drone on about here can be cleared up with a call to DI. I spoke with him specifically about this and it’s a non-issue.
has anyone gotten a response from DI/management on the “November 2022” completion date?
honestly if we moved all this DD over there, we would probably garner more investors and have better outreach
The more I’ve thought about this AACR debacle, the more I think this could be a blessing in disguise. Where they might not have reported results beforehand, they could now be the first major medical outlet to report the trial’s success—and word would propagate from there.
This hinges on them not just retracting their report on DCVax, but issuing a full account based on the NYAS presentation—passed both primary and secondary endpoints with flying colors, long tail, first hope for GBM patients in 17 years, applicable to all solid tumors, etc.
could you share examples of this happening with other companies?
You're stuck focusing on the "fourth secondary endpoint" when the primary and secondary passed with flying colors (p=.001, .002). You're also stuck focusing in old, blended data which we don't have details on instead of the final, unblinded data.
The primary and secondary endpoints, which have definitely been accepted by EU and UK RAs, and now more likely than ever the FDA, are what dictate if the trial succeeded. And it did, no question. Even if the "fourth secondary endpoint" failed, this is minor.
All of this laid on top of the the dire situation GBM patients are in, it's clear this will be on the market within a year.
Thanks for the reply--that makes sense. Do you think the publication will come out before ASCO, and do you believe management has a strategic plan beyond a journal article?
I'm not so sure, for the reason discussed here: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168832378
This thread^ discusses the same issue--which I think at the core must be that the denominator of the control group varies with time because of available data. Hence, at month 0 there are 1366/1366 alive, but at month 48 there are no longer 1366 control patients that were tracked--and so the 7 alive might be out of a much lower number (I guessed 71 based on the chart), bringing the percentage to 9.9% (as seen on slide 30 here: https://virtualtrials.org/dcvax/dcvax.pdf) instead of the 1% that you list. Of course I COULD BE WRONG (again).
where are you getting 5%, 1%, 0% and 19%, 15%, 11% for the 36, 48, 60 month survivals? please reference a specific slide
nice. many of these types of articles are on their way, with bigger outlets to follow after journal publication (which I suspect will be pre-ASCO). this summer should entail a flood of articles from news sites catching on to how big this is
it’s likely that the denominator was also changing along with the numerator at each month—as in, the original number of patients was not consistent across time because the ECA was comprised of trials with differing time lengths:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168832378
Thanks--this might be the answer (per dmb2): https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168832378
Thank you, this could be the case. This would imply that, to match the chart for Overall Survival in Newly Diagnosed GBM:
At 0 months: 1366 patients in ECA database, 1366 at risk (100%)
At 12 months: 1366 patients in ECA database, 888 at risk (65%)
At 24 months: 987 patients in ECA database, 306 at risk (31%)
At 36 months: 400 patients in ECA database, 62 at risk (15.5%)
At 48 months: 71 patients in ECA database, 7 at risk (9.9%)
At 60 months: 0 at risk? Not sure how 5.7% would be derived
Is this what you mean? I hit a snag at 60 months with a DIV0 error--there's likely something else I'm missing. But this scenario would make sense as not all trial databases followed patients for as long as NWBO did and so more data is available for the earlier months.
that is a MASSIVELY FATTER TAIL than what was shown in the presentation. Please tell me how I can be wrong here. All the numbers at 12 months match, and all of DCVax's numbers match the chart. Only the ECA arm from 24+ months seem (way) off.
Feedback requested:
Thanks to H2R calling this to attention. It seems the charts in the presentation drastically undersell DCVax's performance because they display the ECA with much better curves than the corresponding numbers show. I pointed out some of the potential errors and remade the ECA curves based on the numbers. I haven't even gone through all the charts but they all seem extremely off compared to the numbers.
I hope I'm just being really dumb here, please someone straighten me out. If I'm correct this is ridiculous.