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curious when you say:
“They made no comparison of the placebo patients in this trial to ECA. ECA was smoked by placebo also.”
Do you mean the placebos that crossed over and received DCVax (not a true placebo group) or the resilient/lucky placebos that fared way better than typical placebos by not progressing (not a true placebo group)?
The comparison you’re looking for can’t be done, which is why an ECA was needed.
you and I have been talking about separate issues, then. to rebut this other point you’re making, see point #4 here: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168825736
The details and discussion by those much more qualified than either of us will be included in the journal article soon. I don’t see a random ihub poster being correct on this when doctors and statisticians see differently.
Okay, I'll try again. You say:
thanks. not sure why TLD hasn’t been stickied yet.
good possible catch. would be interested to hear what others have to say on this
how do you not get this? the control group was artificially strengthened because the weakest controls crossed over. by the end of the trial, only the controls that did not progress remained as controls. this is in essence cherry-picking the most resilient people to comprise the control group. and this is why that endpoint was found unviable, and why comparing blended to unblinded makes no sense.
by the end of the trial, any “controls” left were only those who are naturally hyper-resilient and lucky. this is no longer a control group.
a typical placebo patient would NOT experience what the remaining “controls” in this trial experienced. this is the whole reason for the endpoint change and ECA.
i’m redundant here but i’m not sure how else to explain it to you. usually you don’t go out of your way to lie but you keep hammering this point as if you don’t get it
I think the publication date has been set and will be in May, for the reason that they could not utilize their ASCO presence if the journal has not come out beforehand. Also, the whole reason they waited 19 months after data lock to release TLD was to bolster it with a journal article. You don’t go 19 months like that to say eh, change of plans, let’s just get it out.
you know this is wrong, because the only controls left that hadn’t crossed over are the ones that didn’t progress. so your use of the phrase “control” here is not what a typical placebo patient would experience, but rather the luckiest of the lucky. doing this apples to oranges comparison is akin to selecting the strongest survivors out of a pool and labeling that the “control.”
for example, historical data shows 5% survival at 5 years. would you then cherry pick these super-lucky folks and call them the control? that would make no sense, and yet it’s similar to what you’re trying to do here.
everyone else understands this and has for a while, including those at the conference which is why this needn’t be explained to them.
once the dust settles from this shorting attack, valuation will be realized and share price will rise.
only the strongest of the strong placebos remained placebos. the others crossed over. this was hashed out years ago. those in the medical community declare this a clear success.
yeah i think people are freaking out for no reason. the talk in one hour WILL have something new—likely TLD from what I’ve gathered. hold tight.
I asked why the talk won’t be available on-demand after and received this reply:
“Hi Josh,
Since the data is potentially new, we cannot release anything without the speaker’s explicit consent as they currently have a manuscript under review and need to follow certain restrictions on what to publish and when.”
“same data” … “available for on-demand viewing”
DI said “the content of the presentation is not changing”
Yes, and the fact that they are making sure the show still goes on indicates something significant being revealed—a rehash /nothing burger and LL simply would have canceled. Something big is being dropped tomorrow morning and even LL being out could not stop it.
DI just confirmed LL and her son have Covid, content of the presentation stays the same.
I think this part of the reason why registration is grayed out—this is a serious event and people clowning around signing up as Elon Musk made NYAS decide to shut down any more virtual attendance. It’s too bad because a lot of us wanted to hear LL’s talk after years of waiting.
True, but she was a late addition. So the structure of the talks was already in place (with Session titles), then she was added later—maybe after getting the green light from NWBO / the journal.
I’ve been cautiously optimistic and trying to think what other “exciting updates to the phase III trial” there could be, but can’t think of much—ideas?
I see what you mean but also remember the title “Unique Challenges in Emerging Immunotherapies” is not specific to LL’s talk, it’s a Session category that five talks including LL’s is under. LL’s specific talk is titled “Autologous Tumor Lysate-loaded Dendritic Cell Vaccination for Glioblastoma.” Looking at the 15 different Session titles, a DCVax talk wouldn’t have fit anywhere else better—none of the categories inspire breakthrough.
wow you’re right. I was planning on paying the $120 and registering. blocked out the morning and everything. has anyone here committed to giving live updates?
these seem reasonable
for 9.5 hours
an almost perfect cup and handle is in the making
Wow, impressive lineup and HIGHLY DC-Vax-oriented
with this vertical launch and high volume seemingly out of nowhere, I find it hard to believe there wasn’t some sort of leak / upcoming PR
Nice work—and to add to this, here’s a previous post of mine also pointing to June 1st:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168344801
Interesting how timing of typical peer review process, expectations based on DI remarks, chart technicals, ASM, and yes, ASCO, all point to the same timeframe: first week of June. Not saying I'm expecting anything because we've gotten our hopes up before just to see nothing, but it does seem to all be coming to a head more than ever.
Who is “he”—and where is this chatter? Thanks
How big this is depends on what the "things" are that she says were submitted--SAP or data?
From her description of the FDA's process, a lack of a negative response does mean a positive response.
How is this not huge news?
thoughts on when they’ll apply for GMP using Flaskworks?
I don’t think it virtually assures approval, but I do think it virtually assures SAP / ECA acceptance by the FDA—which in turn gives DCVax a great shot at approval if data is anything like what we believe it to be.
I was also floored at how weak Ex’s bear argument was, especially in light of recent FDA guidance / Lancet article etc. Everything is pointing toward DCVax showing SS when compared against external controls and approved for GBM SOC. Seems like it will be one of the first evaluated against an ECA, and the FDA is excited to do it—no wonder it’s taking longer than usual.
good thinking. of course, this could mean they submitted and were rejected—or even that they tried several years ago with interim data. would Bosch really be the one submitting the article? I would think LL
well put
citation for the 12 months to release TLD? I’ve seen that thrown around but never seen it backed up
where did the information that DI said we're in peer review originate from? what was the exact quote?
did DI really confirm that we’re in peer review? to me, that’s breaking silence because it implies acceptance in a journal.
process is draft submission -> acceptance in journal -> peer review -> final manuscript submission -> publication
no? i mean it’s good news and means we really are very close to seeing TLD, just seems odd he’d disclose this