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Sounds reasonable
I agree. Hoping to see MIA come through within the next week.
Don't let the door hit you on the way out.
MIA dump today.
No sign of Advent yet.
I assume NWBO is awaiting the post inspection letter.
Below are some of the beginning highlights from the 10-K I noticed, mostly positives. There is an extensive risk factor section that everyone should read, but that goes without saying.
FORM 10-K
(Annual Report)
Filed 02/28/23 for the Period Ending 12/31/22
https://seekingalpha.com/filings/pdf/16447365
Some interesting items found:
1.)
Looks like extension has been granted to March 20th.
Judge Gorenstein extension only granted until 3/20/23. $NWBO pic.twitter.com/JACaRtzuM8
— Fyre (@fyre02532) February 28, 2023
lol, good point. Not very accurate
Other than accounting for our shares, what strategic advantage would we get for merging with Advent?
Genuinely curious. I know that possibility has been floating around lately.
Thanks Hoff
Can someone send me the photo? For some reason she has me blocked.
Other than a short squeeze, how would a merge such as this benefit NWBO? Genuine question.
We will be worth more than that in 5-10 years.
How rumors are going so far I doubt it.
What would be the benefit of such a merger?
MUST READ
"Assessment of Treatment Response to Dendritic Cell Vaccine in Patients with Glioblastoma using a Multiparametric MRI-Based Prediction Model"
https://www.researchsquare.com/article/rs-2591941/v1
Below, BIO99's excellent overview of this new journal publication regarding DCVax-L:
"Thoughts on the latest $NWBO DCVax
manuscript preprint (de Godoy et al)
Due diligence:
I read today a preprint of a manuscript by de Godoy et al that was submitted on February 15, 2023 to the Journal of Neuro-Oncology entitled "Assessment of Treatment
Response to Dendritic Cell Vaccine in Patients with Glioblastoma using a Multiparametric MRI-Based
Prediction Model". Remarkably and signifying the importance and urgency of this study to the neuro-oncology community, by February 18, an editor had already been identified, reviewers requested anc
accepted. The preprint can be found at this link: https:/www.researchsquare.com/article/rs-2591941/v1
My thoughts are below.
This paper is significant because the neuro-oncology community has had a difficult time identifying with reliability using non-invasive methods whether someone
is truly progressing (TP) or pseudoprogressing (PSP). i.e., responding to the immunotherapy treatment but looking like they are progressing on MRI. This has been a major hindrance for glioblastoma clinical trials and immunotherapy clinical trials in general. And now there
is a way to do so.
It reliably shows that one can, using multiparametric MRI distinguish between the two, and does so using the gold standard of histopathology. This is a very
important step in reliably monitoring of large numbers of patients receiving DCVax in the future and making decisions on their treatment plan.
This is critical data not just for the FDA and other regulatory agencies to feel even more confident in the utility of DCVax, because they can see correlation between DCVax treatment, pseudoprogression via
MRI and the histology of dead and dying tumors. The histology figure in Figure 1B-F is incredibly striking, showing how DCVax has resutted in death of the whole tumor. Note that the numbering of the panels in Figure 1
is rather unconventional, and I would suggest revision of the numbering system to the authors, if they happened to ever read this.
The correlation between MGMT methylation
Ki67, overall survival, and other factors is striking and interesting. it lends further confidence to the conclusions of the JAMA Oncology paper. The Kaplan-Meier (survival) curves in Figure 2 are a hing of beauty. Amazing stuff. And it's quite logical that
urvival is better if Ki67 levels are lower (remember tha it's a proliferation marker).
It also points to a published animal model study of DCVax that I was unaware of (reference 6)., which I wil look at in my spare time.
I love this sentence: "The improvement in survival in MGMT methylated patients treated with DCVax-L could be due to synergies with TMZ chemotherapy [9]."
pecause it suggests that DCVax even synergizes with chemotherapy.
Overal, this study makes the case that one can reliably identify pseudoprogression using a more advanced MRI technique and shows beautiful and convincing correlations between things that matter to neuroradiologists and neuropathologists, who not only play important roles in regulatory agencies and ADCOMs but also play countless critical roles including
in diagnosis, determination of progression or prognosis treatment decisions, tumor boards, etc.
I'm interested in reading your thoughts on the study in the comments below."
https://www.reddit.com/r/NWBO/comments/117mc29/thoughts_on_the_latest_nwbo_dcvax_manuscript/?utm_source=share&utm_medium=android_app&utm_name=androidcss&utm_term=1&utm_content=share_button
Hmm, one of two things:
1.) NWBO is "technically" correct, that you need an MIA before MAA is granted. Team is not yet ready to submit as they are still working on the paperwork for submission, as stated during the ASM.
Or
2.) LP "hedged" and purposely used wording that created the idea that submission is still a work in progress, when in fact it's farther along than we realized; with the goal to surprise the market and investors with UK MAA Regulatory approval far ahead of what's anticipated.
To add; perhaps a rolling review is occurring, and the paperwork that they are still "working on" is the MIA paperwork that is ongoing.
Option 2 would still be technically "truth telling", since we "technically" haven't submitted for MAA yet.
Pretty sure that was sarcasm.
He even posted that it was parody.
Fair point. I figured NWBO would PR the day after the website being updated.
News on a Friday is intended to die over the weekend.
Unless it's MAJOR news and they want it to soak in.
With how the world is, the internet and schools are right now....I'm not surprised.
Most definitely interested in the rumors, even if it doesn't pan out. Keeps things interesting.
If MIA comes this week, imo we will know that the PPS is being pushed down for nefarious reasons.
But yes, a daily occurrence isn’t wrong.
They’re really trying to push this down aren’t they?
Don’t fall for it. Know what you hold.
I would almost rather NWBO go alone, or partner with licencing.
DC-Vax technology is worth more than $23 a share.
If/When MIA approval comes through, I sure hope management states that the BLA has or will be submitted by a specific date.
If we get approval but no timeline on BLA submission, it's going to kill momentum.
100%
MIA, BLA/Approval, Partnerships, clinical trials/combos & revenue.
Those are the targets that I'm tracking.
I get it and agree.
Eventually we'll find out, one way or the other.
GUT feeling*
Someone posted here saying “congrats” and highlighting 2/13.
Also, Thermo was stating that he believes it would come “very soon”.
My optimism is telling me next week, hopefully. Just a guy feeling.
MIA approval makes things become “real”, and those betting on NWBO’s failure will really start to sweat.
Wouldn’t that be amazing
It's a reference, specifically reference 9. Is that considered an author?
MRNA?
Give me a break. NWBO is right in front of their faces.
Likewise, part of me feels as if MRNA will take priority as it has been pushed so heavily by Big Pharma. That’s why imo the UK is our best bet to get a foothold first.
But again, everything is lining up for a stellar take off for NWBO, so we shall see. The recent FDA guidance gives weight to our Phase III work.
So.....about that.
Brown University and it's medical students (within their journal club) reviewing and discussing our Phase 3 JAMA article.
I think it's pretty interesting.
Where is this “field report” coming from?
Good information. Thank you.