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Lol...you're replying to the author
Hogwash Sirwannabe!
Lol...what was your capacity guess again for the two Sawston rooms? I remember it being like MAX 8-10 patients a month and was stated with authority.
Bought at .30 per Carlo Rago recommendation....glad I did!!
Glad one of my stocks is going in the right direction
So sorry for your loss!! My thoughts and prayers are with you and your family
Per TCTrader on Twitter
https://twitter.com/TCTrader38/status/1371816898028040192/photo/1
GLTA
Another prediction just like the big selloff today eh? You're firing on all cylinders
1.30, here we come!!!!!!!!!!!!!!!!!!!
Couldn't agree more with your assessment ATL!!
Has it taken longer than investors wanted? Has it taken longer than management anticipated? Yes and Yes.
BUT...IMO we are on the cusp on something very special not only from an investment standpoint but for patients and families who have crossed paths with GBM. Validation is coming soon and for those who have stayed the course, they will be rewarded!!
Thanks for ALL the DD you have done and made available to this board!!
GLTA
To the moon!!!
Lol...I just love the shout out to SoCalKid from 13' Hee Haw
There's been quite a colorful list of characters over the years that have come and gone. Many whom I wish stuck it out but decided to move on.
Here's to the patience this has taken to get to where we are. LP et al have made alot of enemies along the way (shareholders included) but she/they have gotten us to the finish line and IMO the science will be validated!!
GLTA
When TLD is presented and it's stat sig (across the board) are we allowed to view this as wondrous or will you again spike this as news spun wildly positive.
Just preparing myself, I'm kind of a planner
GLTA
Flip...don't question what JerBear deems wondrous!!
In fact...I believe once we FINALLY get TLD, JerBear will find it less than wondrous.
GLTA
Hard not to want to throw up as I watch the sp plummet!!
Hoping the science wins the day here!!
GLTA
Senti~
Saw this today: https://www.azcentral.com/story/sports/mlb/diamondbacks/2021/02/15/nicole-hazen-wife-arizona-diamondbacks-gm-battling-brain-tumor/4485380001/
Automatically I thought of Dr Hinojosa but I believe he is in Mayo out of Florida? Perhaps between a few of us we can get some info over to the Hazen's regarding DCVaxL.
I will try to reach out to GM Mike Hazen and get him in touch with NWBO.
TIA
Exactly Sojo!
I would rather not flood the market post TLD with these warrants. I'd rather hover around $1.60 d/t warrants being exercised now so that we can see a nice post TLD run up to the $4-6 (IMO) range or possibly higher w/out as many warrants stifling the run up!
We all have this to look forward to very soon
Trying to compare NWBO to other Pharma WRT releasing TLD and or peer reviewed journal timelines can be very misleading.
For example, it was brought up that AMRN only took 2 weeks post DL to announce TLD and then 2 months later for publication. AMRN has ~900 employees compared to NWBO which has less than 20..so there's that small issue. You are also comparing a trial treating and collecting data on patients with high triglycerides compared to a trial treating/collecting data on patients with GBM. Not exactly comparable diseases.
WRT the timing of any Biotech released TLD however they best see fit:
As a matter of public transparency and respect for participants, the committee supports publicly sharing summaries of results for registries and lay-language summaries with participants after publication of an article, presentation at a professional meeting, issuance of a press release, or disclosure to the Securities and Exchange Commission, or no later than 1 year after completion of the trial.
As noted earlier, a publication from a clinical trial is a public statement and discussion about the findings of a trial. Rapid publication commonly occurs with findings that are considered highly important scientifically or clinically.
https://www.nap.edu/read/18998/chapter/6 CHAPTER 4 is a very useful resource!
Based on the Oct 2020 PR from NWBO we are very close:
For trials that are likely to have a major clinical, public health, or policy impact, the committee favors sharing the analytic data set sooner than the 6-month window. More rapid sharing will allow the results of important trials to be translated more promptly into improved clinical care, public health, and public policy after other investigators have scrutinized the data.
To those frustrated by the delay(s) with ANTICPATED TLD by NWBO and COVID's impact:
The disruption of clinical trials due to the novel coronavirus pandemic is becoming an almost daily ritual.
The scope of the clinical trial delays and suspension — like just about everything touched by this expanding crisis — is hard to quantify, but consider this snapshot: Biotech and pharma companies are currently running more than 120 Phase 3 clinical trials with top-line data readouts expected before the end of the year, according to search of a database maintained by BioMedTracker.
The downstream impact for patients and the drug industry could be substantial, even if regulatory agencies like the Food and Drug Administration provide assistance. Without data from pivotal clinical trials, new drug filings will be delayed, meaning some important new medicines will take longer to reach the market.
https://www.statnews.com/2020/03/23/as-covid-19-spreads-disruptions-to-clinical-trial-and-drug-development-accelerate/ LOL...from STAT NEWS
JMHO, I think we have TLD this month and at the latest in March! WTBS, absolutely could be wrong but I've been patient for 8yrs now and I'll stick with the science as opposed to FUD.
For those who haven't talked with NWBO management over the yrs... these threats that Senti brought up have been going on long before DI came onboard as the IR buffer. It's sad and unfortunate. Actionable? I think NWBO has their eyes set on the prize in front of them! Taking action against these threats would prove as futile and wasteful of much needed resources as going after the likes of AF. JMHO
GLTA
I want to thank you again for ALL you have done here to inform us retail and patients of this PUMP/SCAM. Truly a blessing you have taken the vast amount of your time and those in your team/shared basement over the past 8yrs to inform us of this PUMP/SCAM.
To further bolster your artillery of info I'd ask that you take this into consideration as you move forward with your good deeds:
1) Oncologists and other members of the cancer care team would presumably want that information sooner rather than later to be able to more appropriately prescribe those drugs and take care of their patients. But new data that reviewed 100 pharmaceutical company-sponsored clinical trials shows that the median delay from when results are available to publication of complete data was 300 days, with negative findings taking longer to reach the public. The study was recently published online in JAMA Oncology (2018; doi:10.1001/jamaoncol.2018.0264).
“The complete and timely dissemination of clinical trial data is essential to all fields of medicine, with delayed or incomplete data release having potentially deleterious effects on both patient care and scientific inquiry,” the researchers noted in the study. “Even for the most pressing study findings, median publication delays approach 1 year.”
https://journals.lww.com/oncology-times/fulltext/2018/09200/3_questions_on____how_long_it_takes_to_publish.16.aspx#:~:text=But%20new%20data%20that%20reviewed,longer%20to%20reach%20the%20public.
2) From https://www.ncbi.nlm.nih.gov/books/NBK285993/
Taken together, these are compelling justifications for sharing clinical trial data to benefit society and future patients. The challenge is to set clear expectations that clinical trial data should be shared and to agree on how to do so in a responsible manner that mitigates the risks involved. Stakeholders have concerns about data sharing. Clinical trial participants want assurance that data will be shared in a way that protects privacy and is consistent with informed consent. Sponsors want a quiet period for regulators to evaluate the entire body of evidence submitted to them, appropriate safeguards for intellectual property and commercially confidential information, and protections from invalid secondary analyses. Academic clinical trialists want time to analyze and publish the data they have collected and thereby gain appropriate professional recognition for planning, organizing, and running clinical trials whose data are subsequently used by other investigators. Research institutions fear that requirements for sharing clinical trial data will be unfunded mandates. Participant and patient advocates want clinical trial data to be widely available in order to advance the development of new treatments. If data sharing is to be broadly accepted and fulfill its promise, these concerns of key stakeholders will need to be acknowledged and addressed. Moreover, the sharing of clinical trial data needs to be carried out in a way that maintains incentives for sponsors and researchers to develop new therapies and carry out future clinical trials and that sustains participants' willingness to participate in trials.
There are many nuggets in here that you might find informative as you expose future PUMPS/SCAMS
3) As I have shared before, I think you will find this useful to update your underlying agenda: https://www.ncbi.nlm.nih.gov/books/NBK286004/
4) Lastly, I know you brought into question the size of the DCVaxL trial. Spread the word on the stats included below as continue forward with your good deeds.
https://academic.oup.com/neuro-oncology/article/20/8/1034/4922286
Forty-five trials were terminated early. Reason for termination was available on ClinicalTrials.gov for 38 (84%) terminated studies. Recorded as reasons for termination were lack of accrual (19 trials), lack of funding (6 trials), futility (6 trials), drug availability (3 trials), administrative reasons pertaining to protocol (eg, principal investigator left the institution in 5 trials), and safety (1 trial). Median trial duration for terminated studies (all phases) was 31 months (range 11 to 50 mo) for ND and 31 months (range 14 to 71 mo) for recurrent trials.
Based on the number of patients accrued to trials between 2008 and 2012 and the incidence of GBM over the same time period, we estimated that approximately 8%–11% of newly diagnosed GBM patients enrolled on therapeutic clinical trials. In 2010 there were approximately 2035 total enrollments on clinical trials, representing an estimated 10.2% of the annual prevalence (19972 GBM cases) in the US.8 As stated above, this analysis does not account for individual patients enrolling on more than one trial.
The clinical trials landscape for GBM is characterized by long development times, inadequate dissemination of information, suboptimal go/no-go decision making, and low patient participation. Truly amazing this PUMP/SCAM made it to PH III for an RCT..the odds were definitely again them!!
Please feel free to share this info with those in your team and again, myself and I'm sure many here would like to thank you for all your charitable time, energy and passion!!
Ssshhh....TMI
The Knobkabob Gang will never buy it tho so keep up the good work!!
Like I said earlier...they have a MOUNTAIN of data.
But but but...this must be a scam, they haven't released data yet; SAP/Endpoint haven't been accepted; No PR's on BLA/NDA; Foxhound isn't on board....LOL
Oh, it's coming.
Thermo~
I look forward to the day when I can nonchalantly say, "I just threw 6M at that deal!"
Good on you and thanks for always posting useful info!!
GLTA
Hank~
I get one post a day. Been that way for a few years now. TOS for debating with use of colorful words
I know you've been at this a while just like many of us here so I was quite surprised with your question but I will use my one post today to address it.
The amount of data from this trial is vast. This trial whether some want to believe it or not is paving new pathways. How many GBM trials have we had in the past 15 years and how many have met their endpoints? Every, and I mean every aspect of the data collected is being vetted thoroughly while keeping in mind, many would like to see this trial fail. In essence you are answering your own question all on your own. They are handling with such care so that there is zero doubt once data is released.
When I talked about "life's work" I was also referring to Dr. Liau. She is a scientist and this is her life's work. I can guarantee you she wants to make sure all her efforts and that of her team are presented to have as much impact not only on the medical community but also for patients. The last thing she would want is to have her life's work questioned as to its validity.
As to Ex's point. He's gonna believe what he wants to believe and until the data is released (this year mind you) he will continue to call this trial a scam. I expect and can almost guarantee even after TLD is revealed and is found to meet some or all of the endpoints he will take issue from a position of data dredging. Even after approval which I think will come from the UK first, he will balk at this. Everyone has their own agenda.
As an example of unforeseen delays in releasing data. How much time do you think it took to go through the data to differentiate different genetic factors such as the IDH mutation? Perhaps those advisors that LP is listening closely to recommended that these issues be addressed BEFORE not after releasing data. It is my belief there has been a few of these circumstances that have come up all in the middle of a pandemic where everything is shut down, especially in Europe.
We WILL get our data this year. I have been very vocal about my frustrations with missed timelines as well and many I know who invested back when I did almost 8 years ago have sold and moved on due to their distrust in the the management. I get it.
I believe in the science here and I happen to love grapefruit juice
GLTA
on a side note...as to the updated FDA clinical trial registry for endpoints in this trial, NOTHINGBURGER. I believe someone on this board already stated correctly, the FDA does NOT sign off on these and they certainly don't update the trials site. They either agree to the changes or they don't!! Highly doubt you'd see buy-in from other agencies w/out buy-in from the FDA
Reef~
Not going to go into details but after roughly a month of texting and trying to set up a time to talk with DI, we had an hour talk yesterday.
No timelines were given for obvious reasons but the gist of the conversation completely syncs up with yours.
LP to a fault or perhaps a blessing is neurotically making sure every single aspect of the data, how it will be presented, any possible doubt/skepticism regarding the data...is all being thoroughly vetted by the company and it's advisors/new pathways are being paved!! They have ONE chance to present this right not only to a medical journal but to 4 regulatory agencies. They will NOT waiver on this regardless of investor frustration. For many involved, this is their life's work...their legacy.
Lastly, and again I won't go into detail but those questioning acceptance of the changes to the SAP by the regulatory agencies (All 4)...well, continue to pi$$ into the wind. For the matter, those that don't think we will have data this year, stand in line.
With so much focus on vetting the data for journal publication submission, medical presentation and regulatory agency approval one would have to wonder why would all this be happening with negative data?
Just for you LC...Hmmm
No responses from me on this post, it says it all!!
GLTA
BSB~
EMA's CHMP may grant a conditional marketing authorisation for a medicine if it finds that all of the following criteria are met:
the benefit-risk balance of the medicine is positive;
it is likely that the applicant will be able to provide comprehensive data post-authorisation;
the medicine fulfils an unmet medical need;
the benefit of the medicine's immediate availability to patients is greater than the risk inherent in the fact that additional data are still required.
Conditional marketing authorisations are valid for one year and can be renewed annually.
Once a conditional marketing authorisation has been granted, the marketing authorisation holder must fulfil specific obligations within defined timelines.
These obligations could include completing ongoing or new studies or collecting additional data to confirm the medicine's benefit-risk balance remains positive.
EMA publishes the conditions of the marketing authorisation in the medicine's European public assessment report.
The marketing authorisation can be converted into a standard marketing authorisation (no longer subject to specific obligations) once the marketing authorisation holder fulfils the obligations imposed and the complete data confirm that the medicine's benefits continue to outweigh its risks. Initially, this is valid for 5 years. It can then be renewed for unlimited validity.
Here's a recent example for NSCLC
https://www.ema.europa.eu/en/medicines/human/EPAR/lorviqua
Lol...perhaps you only follow unicorn trials?
In the words of Learning Curve...Hmmm
https://www.linkedin.com/in/barbara-diehl-41a1717/?originalSubdomain=ie
Barbara Diehl
Chief Partnership Officer, SPRIN-D - Federal Agency for Disruptive Innovation
https://www.sprind.org/en/articles/barbaradiehl/
https://www.mth-conference.de/programme-2020/speakers/barbara-diehl/
Lastly:
From the 10Q:
In December 2018, recognizing the importance of manufacturing to the Company’s future commercialization, the Company’s Board approved an option pool for external manufacturing personnel with options exercisable for 5.5 million shares. The Company has worked with several manufacturing groups to date. As the Company has progressed towards Data Lock and unblinding of the Phase 3 trial results, the Company has reviewed its manufacturing arrangements and incentives, and contemplated the arrangements needed to start preparing for possible commercialization. As part of that process, the Company implemented the award of the 5.5 million options approved in 2018 to Advent BioServices as part of the option grants described in Note 6 above. The exercise price and exercise period determined by the Board in December 2018 for this manufacturing pool were $0.25 per share and ten years. The Company’s option grants described in Note 6 above also included certain other key manufacturing personnel and consultants in the U.K. and Germany.
And for Ex who states, "nobody knows who Cognates customers are." Certainly looks like NWBO is a customer:
(6)We have possible contingent obligations to pay certain fees to contract manufacturers if we shut down or suspend programs. For Cognate BioServices (in addition to any other remedies) if we shut down or suspend its DCVax-L program or DCVax-Direct program, the following obligations exist, which are not reflected in the accompanying balance sheets.
And for those who questioned if COVID has interrupted this trial in a negative manner:
The COVID-19 situation, and related restrictions and lockdowns, have adversely affected the Company’s programs and are likely to continue to adversely affect them. For example, the process for completion of the final data collection from trial sites for the Phase 3 trial was materially slowed by the inability to perform in-person monitoring visits by the contract research organization, by very limited availability of investigators and staff at trial sites, and by substantially longer timeframes for Institutional Review Board or Ethics Committee meetings and regulatory processes for matters other than COVID-19. The Company has been essentially unable to undertake compassionate use cases during part of March and during Q2 and Q3, due to lockdowns, travel restrictions and hospitals focusing most of their personnel and resources on COVID-19 patients. In addition, manufacturing of DCVax products is impeded by personnel being under lockdown. The start of the buildout of the Sawston facility was delayed by the construction sector shutdown and restrictions, and the costs of carrying out the buildout were substantially increased by the need to employ two construction crews to work double shifts. The Company anticipates that such effects of the COVID-19 situation are likely to continue for an extended period of time.
Lastly, as other have posted:
Consulting Agreements
The Company is in the process of entering into expanded agreements with certain Scientific Advisory Board members and certain other key consultants whom the Company anticipates will play important roles in helping the Company prepare for potential applications for regulatory approvals of the DCVax-L product. The agreements are being negotiated around structures that are wholly or partly contingent upon major milestones and will provide substantial incentive compensation.
Some will balk at LP's self dealings as a distractor from what is obvious. NWBO is moving forward with publication of TLD, manufacturing and the consulting required for approval. That speaks volumes.
Take emotion out, read what is written and ask yourself why the company would be moving forward if the trial had failed? And yes, they are well aware of the results!
GLTA and stay patient!!
Albeit from 2015, a very informative paper regarding the Clinical Trial Life Cycle and When To Share Data:
https://www.nap.edu/read/18998/chapter/2
There's alot of info available here and worth going through given it is directly applicable to where NWBO is right now with preparations for releasing data.
Did we lose Longfellow?
Hoping we all hear something this week!! If not, I guess there's always ASCO
GLTA
Me too!! 68' 289 C4 auto, metallic blue w/white pinstriping.
What a car to have at 16, only $2500 back in the day. Dad told me he'd match what I saved so I started doing any work I could at 14 during the summers.
Like an idiot, wrecked it my first year at college racing a 280Z. Smoked him off the line but handling the tight turn did not end well for me
Closest pic I could find online...miss that stang everyday!
Great stuff aperture!!
Best to you and blessings in 2021
ATL....here's a good read on the Roadmap to using HC's in clinical trials.
https://ojrd.biomedcentral.com/articles/10.1186/s13023-020-1332-x
as well as: https://journals.sagepub.com/doi/full/10.1177/2168479018778282
and:
https://www.futuremedicine.com/doi/full/10.2217/fon-2020-0591
WRT AVII, he will argue for the sake of arguing. Mind you, this is the same guy over at the Village along with others that emphatically stated that the DCVaxL trial data would never see the light of day.
I'm patient and have been patient and certainly want to be more calm and patient like others but this is getting a bit ridiculous.
Going back to 2014 every time I have called IR (LG) then and questioned timelines I was met with a hostile response about not understanding what the company is up against and the nefarious forces.
Fast forward, now I deal with DI whom I at least have a little more respect for but I get the exact same response as LG?
I'm gonna continue to be patient and I hate..HATE feeling this way, like I am giving fuel to the naysayers but Good Lord, some sort of accountability would be nice.
Current Magic 8 Ball response is cannot predict now. Go figure, year of the RONA. Hoping we get some answers in 2021 and hopefully before ASM or ASCO.
Single post allowed for not always being so patient with others
Doc L~
Just felt the needed to tell you that I find you to be an amazing human being which in this day and age, I don't say very often!!
Probably sure our paths will never cross but I hate to say never.
Your demeanor is refreshing and I always appreciate the time, care and grounded approach to which you post and respond to others.
Your faith is unwavering and quite compelling.
I wanted to let you know that I pray for you as I feel the world could use more Doclogic's.
Best to you and thanks for always being a class act on this MB!!
Utmost Respect