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Mr. Williams is not an MD
I haven’t researched the others, but regarding the first guy Matt Williams:
“He took part in the first UK expanded access scheme to use Optune widely, and runs the UK's largest Optune clinic.”
no conflict of interest huh?
https://www.topdoctors.co.uk/doctor/matthew-williams#
3.5. But, it really is only a matter of time.
Do you think a buyout/partnership is possible, or is that far-fetched in your mind?
Could you please share your thoughts on the matter?
is there a link to stream SNO presentation tomorrow?
I use etrade and don’t see this?
Here we go folks, the full package has arrived and this is just the beginning. Tomorrow and next week we will rip up once news spreads. JAMA, wow!
Nice thanks. Definitely possible, but the “coincidence” of NEJM lifting embargo at 8am Sunday and LL speaking 8am Sunday is not really true since the 8am embargo lift is just an example, not when they routinely do it
but that link also says Thursday 12pm “draft abstract available to media.” our abstract was available well before then. Also that whole table of times & events is labeled as an example
That appears to be correct, though—look at all other presentation abstracts, they all have the Journal Article tag. Unless you think every single abstract/presentation will have an accompanying publication.
looks like you have 200 EMA not MA input. either way, things are looking good
what are your thoughts on the new authors? I’m trying to see how else they could be connected to the presentation/abstract, if not for a new publication
this and the fact that there are new authors listed on the abstract that were not authors of the JTM paper—so, what are these new folks authors of then, if not a new impending publication?
can you provide a source for the combo trial data you’re referring to?
this makes sense and i hope you’re right. but i won’t be holding my breath either.
not so sure—she could’ve said that to a crowd that was largely unaware of the NYAS presentation?
agreed—either the journal comes out before SNO and LL can give a quick overview of its contents, or if it doesn’t, SNO will be a brief rehash of NYAS. I don’t really see any other alternatives. Because of the short ten minute time slot, I’m thinking it’s the latter but hope I’m wrong.
If they are abandoning journal then she’d need a lot more than 10 min to report.
Another scenario is a brief regurgitation of NYAS—still not breaking journal embargo as it’s UCLA not NWBO (as was NYAS). As in, in my mind this quote from LL doesn’t negate the possibility that SNO is another NYAS and we’re left in the same spot—limited TLD info and waiting for journal.
curious what makes you think it implies something more than NYAS?
the comments on this lol
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it’s not too late to change ships ex
do we know how many are enrolled in this combo trial?
great to see, thanks
it is literally the next bullet point, scroll below what you copied in the document. the point that you’re trying to make—that RWE is derived from non-clinical RWD only, while the FDA definition of RWE states that it can be generated from clinical trials, doesn’t add up. sometimes you have good points but on this I don’t think you know what you’re talking about.
you intentionally left out the next bullet point defining RWE:
RWE is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated from RWD using many different study designs, including but not limited to, interventional studies (clinical trials) or non-interventional (observational) studies.
note “clinical trials”
your assertion that NWBO’s ECA has nothing to do with RWE contradicts the FDA’s definition of RWE
what made/makes you so confident so as to post things like this?
this is what i was hoping to see. thanks.
Can someone who knows more than me clarify if our ECA design falls under this new FDA guidance? I would think that historical clinical data is more robust than RWD and sets a higher bar, though I see the two concepts are separated:
https://www.clinicaltrialsarena.com/analysis/real-world-data-charge/
The FDA guidance addresses RWD, but not really ECAs consisting of historical clinical data. Again, I would think NWBO’s ECA is made of higher quality data than RWD, but looking for others’ thoughts on this. Thanks.
are you suggesting it would have been better to create the control arm from RWD than from historical clinical data?
makes sense to me
to verify, the “extra dimension of efficacy” was not presented in June, correct? as in, if it exists, it is yet to be presented?
yeah and then “we’ve never applied for approval before… we’ve never been granted approval before… yeah well we’ve never had revenue before… well we’ve never been SOC before…”
you’re marking progress milestones like they’re a bad thing
so what do you think of Linda Liau’s claim that it does provide a survival benefit? Does she just not really get it, like you do?
based on that, what’s your best guess for MAA submission date and certification date?
so what do you think the hang up is?
at least you’re on record now explicitly stating you think you know the science better than Linda Liau. This presentation is not by NWBO, but a prominent scientist—an important difference.
ex, curious how you stick to your guns that the trial failed (your reiteration of “but placebo vs ITT!”) when Dr Linda Liau’s SNO presentation is titled:
“DCVax improves survival in newly diagnosed and recurrent GBM: survival results from a phase 3 trial”
Is she in on the scam, and lying? Why would she, or better yet how could she present with this title if your narrative is correct?
Furthermore, for everyone, just imagine if we saw this abstract title a year ago, lol, everyone would be hooting and hollering. But for some reason—the short takedown in May? the current share price?—folks now see this title and just say “yeah we’ll see.”
but survivors took DCVax + SOC? hopefully one day we’ll see what DCVax can do without the immune system compromised, but for now everyone is still getting chemo
i don’t know what that means, and there was no link