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Q1: 40%
Q2: 45%
Q3: 10%
Q4: 4%
2023 1%
Happy New Year JRIII. I’ll admit that you and others were right when you predicted no TLD in 2021 and I was 100% wrong.
I’m not gonna argue about how the FDA will view the SAP changes, although I agree with Gary.
I’m not sure if you’ve ever experienced first hand what it is like to watch someone you care about suffer and die from GBM. It is an understatement to call it a horrible disease.
Everything about GBM is torture, from the lack of any treatment that works, to the brain trauma and rapid decline, to the horrible side effects of the current SOC, to the hopelessness and helplessness of patients and their families - mothers and fathers, sons and daughters, husbands and wives, brothers and sisters.
I can tell you first hand that my friend who got DCVAX at UCLA is still alive and enjoying life 9 years later, while my stepfather lasted 6 horrific months that I can’t even begin to describe. I’ll just say that we had to lock his doors and hide all the knives in the house because the man we knew was long gone and replaced by an emaciated memoryless wreck with traumatic brain injury who didn’t even recognize his own daughter.
So I respectfully ask that you consider the effects of GBM on millions of lives and the FACT that DCVAX safely extends many peoples lives (OS) far beyond any approved treatment and without any of the horrible side effects.
For the sake of those suffering from this devastating and heartbreaking disease, let’s all hope DCVAX gets approval and quickly.
If it doesn’t based on the use of historical controls due to compassionate crossover of the trial’s original control arm and a reordering of endpoints to address a newly discovered issue of pseudo progression, then it will be be one of the biggest travesties in the history of medicine. The suffering of us investors will pale in comparison to the millions of patients and families that will be destroyed.
So many variables in terms of timing. I think we get TLD, publication, MHRA approval and FDA BLA submission by 2023.
$8.25
A more specifc question would be what is the market cap and I think it will be about $14 billion
Hey Hope, happy holidays!
I haven’t done any additional due diligence that hasn’t been shared on the board… certainly nothing to make me think TLD is “imminent.” Unfortunately I won’t be surprised if Q1 comes and goes without TLD, but I am hopeful that we will get it before the ASM.
Like you, the theory that they are waiting on the FDA to finalize guidance that directly impacts the way the data will be presented to the public and in the BLAs makes a lot of sense to me.
My understanding is that this guidance is supposed to be finalized by the end of this year. Based on the current share price, the recent MHRA GMP certification, and the likelihood of an “organic” bottom, IMO the time to add to my position is now… when the FUD is at “all time highs”
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167201354
Thank you my friend.
Reminds me of a bigger version of the .40-.26 bow ;)
Sojo helped me time my entries at .28 and .27 right before we ran to 2.50
I am extremely bullish on NWBO LONG TERM, so I’m using TA to time my entries… I’m not under the impression that TA will be right 100% of the time.
Make sense?
BTW I’m as frustrated and exhausted as anyone, but my DD is done and I am accumulating here.
Cool thanks Ex! I’ll definitely consider going short ;)
Maybe you could post a chart showing that gap to aid in my analysis.
Hey chart people:
Is the gap at .68 (close before gap) or .70 (HOD immediately before close day before gap)?
Thanks again Sojo, so are you saying that because it didn’t break out you think it will be filled? As disheartening as that is (mostly because I pulled my attempted swing trade sell orders at .88 and .89) I guess it’s just another buying opportunity before the real news.
I’m fairly confident we get TLD/publication before ASM
Happy holidays and thanks for all you do.
Thanks Senti, that’s another good point.
Scotty I’m sorry but I’m not understanding what you are saying. You seem to be implying that the crossover patients that got DCVAX are still counted as part of the control arm???
My understanding is that the crossover patients that progressed (tumor respected and then returned or spread) and THEN were given DCVAX were in fact being treated for RECURRENT GBM. As.such, they essentially became a trial within a trial for how recurrent GBM responds to DCVAX, hence the inclusion of rGBM in the revised SAP.
I appreciate you addressing my question Sojo, I assumed you’d missed my post. Interesting analysis as always, thank you.
That’s what I meant to say ;)
True, I’m not sure what they are, as they claim to own no shares. To be clear I’m not referring to the poster I was replying to.
Perhaps I’m misunderstanding.
I assume you are referring to their original primary, prior to buy-in of the revised SAP by all 4 RAs. This occurred PRIOR TO DATA LOCK AND WELL BEFORE UNBLINDING.
Their original primary was PFS so the issue with that would be pseudo progression more than crossover. I don’t think it is a certainty that PFS failed (we’ll see soon but IMO it’s 50/50) but they 100% did NOT know that it failed. Yeah the issue of pseudo progression did cloud the analysis as did the small and essentially invalid control arm.
They revised the SAP to deal with both pseudo progression and crossover, and in doing so, they greatly increased the chances that the trial did NOT fail (99.9% IMO) to meet the primary endpoint OS measured against historical controls.
Anyway, maybe I am missing your point, but it blows my mind that bears are still arguing the trial failed rather than criticizing the SAP revisions.
Exactly, the bears are using lots of bold, talking bubbles, and seeing red ;)
BTW senti is a woman.
Question for Sojo or Judge or whomever:
I love NWBO and the news, but I hate gaps; up gaps always seem to get filled (e.g. the infamous .875 micro gap.)
Do you have any TA reasons for why this morning’s gap either won’t get filled or isn’t technically a true gap?
I really want this news to be the change in momentum where suddenly shorts are scrambling to cover and longs are scrambling to get in under $1…
This guidance is almost certainly what LP is waiting on, because it affects the very way they present the data and the BLA itself.
Ah, “genetic subgroups” and “historical control arms,” two concepts that I never imagined I’d be thinking about so frequently ;)
Also interesting that they were concerned about P values and partial approvals based on unspecified subgroups in 2020. A very good argument though.
Completely understandable why they’d want historical controls and another fantastic argument.
LL’s statements were eye raising too, especially the Optune smack down.
That’s what he told me, so I’ll bet you a steak they PR it tomorrow ;)
The TLD 2020 statements and subsequent lack of communication by management for 15 months are definitely not typical or even remotely desirable for retail; however, they’ve pretty clearly made the decision to withhold a TLD summary PR until publication.
Unless you’re in the “NWBO are just a bunch of criminals hiding a failed trial” camp (which I know you aren’t), we have to wait for publication to get TLD and that’s that. I know for a fact that TLD itself hasn’t changed since we were at $2.50.
I fully agree with your assessment Doc… What price do you think their targets are?
As much as it pains me to say it, I’m thinking .52 or even .47
Scary to think the last time we saw these prices was pre data lock, pre endpoint revisions, pre historical controls, pre flaskworks acquisition, pre Sawston buildout, and pre MHRA manufacturing certification. I know it’s cliché but nothing has changed as far as those amazingly positive developments or the final data since were at $2.50 other than the company’s decision to withhold TLD until publication. We will look back in a few months and wish we found a way to buy more in the .50s, I’m as sure as I’ve ever been about that.
I’d also say that I think the nefarious forces are timing this all to maximize the uncertainty because they know we won’t have TLD in the next couple of weeks. It’s all pretty disgusting but sadly nothing new ,in fact the opposite is true too when the price spikes massively right before BAD data e.g. CVM, IPIX, etc…. wish I could not check it till the end of February 22, as I things will be very different then.
Hope you are well Senti,
Can’t stand Optune and their unscrupulous trial, but I will say that my father-in-law is still alive 4 years after resection and wears his helmet every day, so maybe there is something to it. Or maybe it’s all the turmeric :)
You make a good point about the biologic vs medical device. It still makes me nauseous to think about NWBO’s performance versus NVCR over the past several years… but I guess that’s water under the bridge at this point.
Hopefully we’ll all be happy campers by the end of Q1-2022
I laughed out loud :)
Happy Chanukah my fellow tribesman!
Hey, thanks so much brother!
Hope you and your family are healthy and well.
Great points, the ability to stay “financially patient” is very much a luxury when it comes to investing. Although I completely botched several swing trades and then averaged down way too early, thanks for the reminder of how blessed we are to be able to maintain our core holdings through this trying period.
Thanks also for the DM
Mahalo for the reply and additional info ATL! I can’t tell you how much you and the rest of the knowledgeable people on here that share their DD have meant. I occasionally share your posts with a DcVax GBM survivor who is also an NWBio investor. He even asked LL how it was going at his last follow-up…
“very busy” was her reply ;)
Point taken biosectinvestor, I guess I was more acknowledging that he’s smarter/more knowledgeable than the average bear on this board.
Unrelated note: Am I on the right track with this?
https://www.regulations.gov/docket/FDA-2019-D-4964
Ex strikes me as an industry expert. He’s always correcting points that only someone with a lifetime of experience would know. Unfortunately almost all of his posts are bearish even though he has shifted his focus away from the trial failing (he seems to acknowledge the new primary will be met) and more towards tearing down the trial itself and approval chances. This is a predictable shift since bears who argue the trial has failed and management is hiding it are IMO completely clueless.
Glad we agree on something Ex :)
Actually, I find your knowledge of the industry very interesting. I wish you wouldn’t always make the bear argument, but I guess we have plenty of people always making the bull case.
Gary, you are one of the most genuinely good people on this board and my heart aches for your sister and her family. praying for her health and strength.
Hi MID, not sure if you are referring to the insider ownership interest on IHUB or something else, but it does state 4-16-21
Ok fair enough, believe it or not I’m not a management apologist nor am I under the impression that the final data couldn’t be mixed or even problematic.
I do believe is that LP will do everything in her power to maximize the value of her 120,000,000++ shares/warrants/options, and I also believe that we’d know already if the trial had failed its primary endpoint.
Good luck to you.
What in the world gives you the idea that LP has secretly disposed of 90 MILLION SHARES (warrants and options)?
You realize the sale of shares by insiders is required to be disclosed right?
https://www.investopedia.com/terms/f/form4.asp
Security Holder - Linda Powers, CEO
29,411,759 common stock
Note: all warrants and options held are not exercisable without a 61 calendar day notice, and thus, are not considered "beneficially owned."
Numbers shown below to be confirmed.
39,371,570 common stock warrants not beneficially held without 61 calendar day notice (as of 3/27/20 proxy)
39,200,00 common stock options beneficially held without 61 calendar day notice (as of 3/27/20 proxy)
Thanks for sharing with the board.
I do believe he is telling the truth every time he implies that if the trail failed they would have told us. Which is of course another way of saying the trial met at least it’s primary endpoint.
I wonder about the lack of large bids at these levels as well. Maybe everyone did what I did and blew their powder way too early because they never thought we’d hit .75 :)
Just realized there is no Trademark symbol on the 2018 bag! There is one on the 2021 bag!
WAIT I’M WRONG! There is no trademark on the 2018 bag!!!
Hopefully this ends the bag talk once and for all:
https://stocktwits.com/mne30m3/message/409020481
He said buy-in by all 4 RA’s. As in they did not disapprove.
I’m not sure if there is such a thing as a formal SAP approval prior to approval. I think the RAs either approve or disapprove and the SAP is what they consider in that decision.
Thanks, you too!
I totally understand that there could be any number of delays in TLD and it could be months after the policy decision. I’m less concerned about timing anymore, and more interested in which policy decision might be central to the analysis...
If we should be focusing on the non-IDH GBM survival curve in both the historical controls and the NWBO interim data, that would be quite a different set of data points to analyze.
Hi Bio, long time, hope you are well. Taking a break from the board for sanity/family purposes.
I wanted to ask if you’d be kind enough to let us know when the FDA does decide on the policy issue that you mentioned last week?
Based on a few other posts my guess is that this relates to IDH mutations, but I understand if you don’t want to give me a warm or cold ;)