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Care to tackle the failed trial results Ex?
Like clockwork!
Now let's hear you explain the failed trial results
W/in the first 7-10 trading days of Nov. Even LowGo will be speechless
Thanks Reefrad!!
Flip
I don't swing trade this stock at all, never have. You have called me out on being vocally frustrated in the past and then coming around to being upbeat and encouraged. Management in my experience without disclosing non-public info has paitned a picture with shareholders of things/events to come for years now. When those events don't happen and you question management about them, it is met with a verbal lashing.
I find it astonishing that after years of conversing with managment and more recently DI, that they will no longer take my calls or respond to emails/texts with questions and frustrations I have over timelines not kept by them. I along with many others have been nothing but supportive over the past many years. This lack of accountability and transparency is exactly what is huring the stock and overall market sentiment. And yes, I do understand the other side of this arguement that NWBO has tried to be transparent in the past but they were attacked publicly when they tried to be transparent.
I have been involved in many other R&D/clinical trial stage biotechs and this management team is appauling. Maybe this will all be revealed at some point, heck LG has been telling me that since 2016 post the Phase 5.
As many longs here have voiced frustrations with management, I'm sure I will be chastised for being vocal but good Lord, at some point management has to $hit or get off the pot.
The wait continues, for how long is anyones guess.
I'm a believer in the science here!! Management, well...not a fan until proven otherwise.
GLTA
They are trying to figure out what to do next...it's a day by day thing. They've proven themselves again and again to be unable to execute any sort of plan with transparency to their shareholders.
My guess is they are negotiating how to tell shareholders they need to continue to stay patient for another >>>months.
Beliieve in the science/DCVax getting approved but management is atrocious!! Will hold strong for science validation.
GLTA
Are these folks on payroll?
External control arms in oncology: Current Use and Future Directions
Author links open overlay panel: P.S.Mishra-Kalyani1L.Amiri Kordestani2D.R.Rivera3H.Singh23A.Ibrahim2R.A.DeClaro23Y.Shen1S.Tang1R.Sridhara3P.G.Kluetz23J.Concato4R.Pazdur23J.A.Beaver23
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
When to Consider an External Control Arm
-Rare indications with high need, urgency, or poor outcomes
-Therapies with large benefit versus risk
-RCTs are unethical or unfeasible, resulting in significant delays to patient access
-Scientific concerns about treatment switching/cross-over or other barriers to RCTs
The application of ECAs can be for regulatory approvals, label expansion or changes, medical affairs, or market access and reimbursement.
Certainly appropriate to have the underscore after Dr
I recall Thermo mentioning PB & J
💥 Just released 👉2021 Top 5 journals with highest impact factor 🏅🚀
— Vivek Subbiah, MD (@VivekSubbiah) June 28, 2022
1. Cancer Journal for Clinicians - 286.13
2. Lancet-202.7
3. NEJM- 176.07
4. JAMA-157.3
5. Nature Reviews Mol Cell Bio-113.9 #medtwitter @OncoAlert pic.twitter.com/d1v0iwX29f
Exactly Flip!!
You really seem to get stuck in the past "Ex"wannabe.
I would imagine when Sawston is up and running at full capacity (more than 4-6 patients per month right?) you will still be discussing Cognate and Toucan.
Ex, being an objective person I hope you take time to listen to Dr KA regarding the results of the DCVaxL trial
https://drive.google.com/file/d/1afp0oxGSXOzswfhkNq8YY7EiyQQspMhz/view
Given your concerns about the post hoc/unblinded changes to the trial endpoints you may want to start listening at the 9:30 mark of the video
At the 15:22 mark of the video, Dr KA should relieve all your worries about the SAP, when it was submitted and that in fact all regulators approved of the changes unless of course you think that Dr KA is publicly lying about the integrity of how this trial was conducted?
At the 17:18 mark in the video Dr KA addresses your concerns wrt inclusion criteria and cherry picking results for patients who had favorable prognostic factors.
What do you think of the OS PValue and HR for patients over 65? Crazy huh!
Also, what did you think of the mOS in rGBM?
20.7% vs 9.6% at 24 mos after recurrence
11.1% vs 5.1% at 30 mos after recurrence
Crazy huh?
Appreciate your open mindedness to listen to Dr KA's presentation and objective response.
GLTA
The IDMC usually consists of a group of independent experts that evaluate the accumulating data from a clinical trial with regard to the progress, safety of study participants, critical efficacy endpoints of the trial and make recommendations regarding trial modification, continuation or termination.3 9 The function of the IDMC is not to be confused with that of a typical study steering committee (SSC) (also known as the steering committee, clinical trial steering committee, study executive committee or study executive board).3 9 10 The SSC may be responsible for designing the trial, has the executive power over the trial, provides overall supervision and maintains the quality of trial conduct.3 9 10 While the IDMC may receive unblinded data in order to make their recommendations and is typically composed of experts not involved in the trial itself, the SSC members play a very active role, for example, as investigators, but remain blinded while the study is ongoing
Critical decisions in such trials should not be taken lightly, and a clear understanding of the stopping rules for the trial is needed. In oncology clinical trials, special consideration needs to be given to early stopping rules and efficacy, to avoid making the mistake of stopping a trial too soon if there is, for example, a possibility of a delayed divergence of survival curves (eg, as may be seen with immunotherapy or in case chosen surrogate endpoints in the trial do not adequately predict or reflect more definitive outcomes such as OS).13 30 Other study results that might become available while the trial is ongoing, competing risks or changes in the standard of care during study conduct, also need to be considered for their potential impact on the ongoing clinical trial, the ethical implications and for maintaining the patients’ best interests.1 15 This highlight the importance of selecting IDMC members with a high level of expertise and comprehensive insight in the ever-changing landscape of cancer treatment.
While the IDMC members can be in the unique position of having access to unblinded data, they have the obligation of maintaining the integrity of the study when communicating with the sponsor. If the feedback from the IDMC meeting to the sponsor requires more than a simple statement and some details are included, or in an open session, it could become an issue in keeping the interim data of a study blinded particularly in trials with a 2:1 randomisation (where it can easily be seen, based on recruitment figures, which arm reflects the investigational treatment). Careful thought is needed in these communications to the sponsor to ensure that the data remain blinded.
https://bmjopen.bmj.com/content/11/10/e047294
Great. Please provide source that sponsor/NWBO was unblinded to any analysis?
TIA
Hey Ex, what's the role of the TSC and DMC in a clinical trial?
Was this not enough for you Ex?
Per NYAS Dr Mulholland:
Progression Free Survival & Pseudo-Progression
Original primary endpoint, when trial designed in 2007:
Progression-Free Survival (PFS)
While the trial was underway, Pseudo-progression (PsPD) became
recognized as major issue -- difficulty distinguishing real vs. PsPD
PsPD is an even bigger issue with immune cell therapies:
vaccine-induced infiltration of immune cells
PFS endpoint not feasible due to PsPD. So, SAP focused on OS,
and specified OS as the primary endpoint before unblinding.
Keep spinning Ex
Many Doctors have and many more will be commenting on the DCVaxL stat sig trial results.
You finding anyone who listens to your minutiae? You're a finance guy right? Stick to your lane
DCVaxL TLD better than TTF w/out having to wear a helmet for 18hrs/day, better safety profile and much better much better OS with rGBM. Doesn't sound like "nil" to me or actual treating docs in the field.
It will be good to have Dr KA speaking at ASCO and perhaps some updates form MB and of course, new tote bags are always a nice gesture
Certainly would have hoped that the publication was all lined up right after NYAS...so much for all those ducks lined up.
GLTA
Hahaha...the smelll of desperation here is overwhelming. Perhaps consulting with a real physician such as the troll @MidwestHedgie will bolster your position. Hell, he and AF can run circles around in the field physicians as well as RA's.
NWBO/DCVax certainly is getting ALOT of attention from those who are 100% certain the trial has failed and apparently have zero position.
You have to wonder why AF is attacking physicians involved in this trial? Certainly couldn't be a short position at stake here
Happy Memorial Weekend Ex!!
GLTA
NO...pretty sure you stated they had to be unblinded when they made the SAP changes but go ahead and stick with your agenda.
BTW...Is PFS now your gold standard primary endpoint in Immunotherapy as well? SMH
GLTA
Weren't you the one claiming the NWBO was unblinded when they made changes to the SAP?
Swing trade it? What the hell are you talking about? The last time I sold a share was in Jan of 2021 and since then have only added back to my position.
Are shareholders not allowed to be frustrated due to the lack of execution over many yrs?
As to XYZ, you have no idea of conversations I or other shareholders I speak with frequently have had with the Company.
Are you telling me that publicly stated PR's and timelines given by the Company over the past 8 yrs have actually occurred?
You're allowed to take your holier than thou approach to all topics on this MB and frustrated shareholders are also allowed to vent...it's that simple.
Science will prevail but management is abysmal.
GLTA
tryn2 consult with Jesster, his 7 months of investing here and breadth of shareholder/Company knowledge surpasses anything you have been through over the past many yrs.
Simply sit tight, nod your head and know that all your concerns and worries are unjustified.
Good to know I'm not the only one who's convinced multiple friends and family to invest here only to be lambasted by them over how management has handled matters and missed timelines over the past "many" yrs.
I'm all for the endgame Jesster if that's what we get.
How long have you been here? Looks like 2021. You only missed out on one XMas card...how nice.
Some here haven't had a XMas card for 8 yrs. Pretty sure this is a publicly traded Company that has fiduciary responsibilities to its shareholders.
Our perspectives are different obviously. Never stated shareholders were "duped" but I did state it's time to deliver. Not sure how that's confusing to you?
When you as a shareholder you are told XYZ (publicly) is goin to happen, then it doesn't happen and there is no comment by the Company nor is there ever an explanation as to why it didn't happen then you start to get concerned. When this scenario plays over and over again then concern becomes reality.
Again, I 100% believe in the science here. Again, I do not believe that LP gives one flying $hit about shareholders. Again, absolutely fine with being wrong.
Been in this alot longer than most here and actions speak louder than words and in the case of LP, she hasn't spoken "words" to her shareholders in yrs.
Will hold thru ASCO and publication of data and reassess if management has any sort of plan to execute.
GLTA
Thermo~
Completely understand financially supporting the Company to get to a point where the ROI for investors is realized.
WTBS, there needs to be some level of accountability. Shareholders have been IMO blindly supporting the Company for long enough...it's time to deliver FFS!
I do and have always believed in the science here but LP/LG have time and time again proven themselves to be unbable and unequipped to handle what is in front of them. I do truly hope this time is different but I have my doubts in spite of what I feel is amazing trial results.
I actually don't believe that LP even realizes the damage she has done to shareholders who have stuck by this Company thru thick and thin over the past 5+ yrs nor do I feel she actually cares about shareholders. For her, the ends justify the means and that is all that matters to her.
I am not stating all of this to deter, distract or create unnecessary angst with shareholders but I do feel there is a majority of long term shareholders that feel this way. When is the last time that LP actually spoke to her shareholders? It certainly wouldn't be too much to ask to have the CEO of a Company come out and thank shareholders for their patience in light of missed timelines for the past 5yrs. Instead shareholders are left to try and fill in the blanks and guess as to what the Company is doing and hoping its in their best interest.
Anyway, sorry for rambling. Very very long on this and have been in it since 2013. Still believe in the science 100% but honestly don't think this management team is equipped to fully deliver the value to its shareholders.
The science is solid, management, well....so so at best.
GLTA
Did the DCVax trial have a DMC and Steering Committee? Pretty lame angle even for you but for those that want to refresh on the various roles of the DMC, here ya go:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5380168/
GLTA
If we are going to have an honest discussion about the harm done then we should also probably discuss the harm done to our kids over the past 2+ yrs let alone the increase in abuse, anxiety, depression, suicide etc... This does not even take into account the deaths related to people not being able to go into hospitals as well as eldery dying alone without even having their families by their side.
To not acknowledge this is just as ignorant! This could have been handled so much differently and effectively while not being made so political.
OMG
Lol... a link to the vm. Best one yet Ex, you're the gift that keeps on giving!
GLTA