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Great post
The fda, while the most important stakeholder, is not the only stakeholder. There are doctors, patients, patient advocacy groups who are important stakeholders in ensuring the treatments positive perception and awareness.
The CEO of CVM was also tweeting up a storm pumping up the results. Linda Powers would never do that. The results will speak for themselves in due time.
Bio, don't you find it amazing how some talk out both sides of their mouths when it suits their narrative? Here you have a post assessing how NWBO and CVM cannot be compared:
"One is GBM and the other is Head and Neck. Can not compare them.
But if you wish to, CVM reported against a 5 year OS in the MI w/o chemo population. Even is the MI + chemo partients drop it, will still be 40%+ or so.
DCVax-L has no chance of hitting those 5y US numbers.
I will repeat that the comparison is absurd. But you are one calling it real DD. So at least get your real DD correct."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166850666
I agree with everything you said.
I personally believe that the primary reason they are waiting to release a publication with TLD is because of the ground breaking impact that this treatment will have, it's ground breaking impact it will have on how oncology clinical trials are conducted in the future, and at the recommendation of the experts that are part of the SAB.
Releasing information too soon without ensuring all t's crossed, i's are dotted could have negative impacts on the perception of the major success this treatment will have.
As I've written on Twitter, comparing to Muhammad Ali's strategy, the body blows they are taking during this delay by leaning on the ropes will lead to an ultimate KO. Go Linda Ali!
I think it's clear that times are completely different 410+ days post datalock.
Except that we're now on the verge of GMP certification,TLD and publication in a very major medical journal. :)
I believe there to be another milestone in here as well. 12/19/21 fulfills the 5 year requirement after delisting on 12/19/16. On 12/19 NWBO shares become eligible for uplisting, granted we meet all of the other requirements around share price, etc. Whether they pursue this year or not, just wanted to put on the radar.
The other key with Flaskworks is the staffing to operate. Those Gmp scientists are very scarce resources and I would assume expensive as well. Flaskworks would amplify the number of vaccines that can be produced per scientist by a similar factor. It should be interesting to see the numbers once they're out there.
LMAO - I'm laughing out loud. This does describe us all very well.
Has anyone gone back through and reviewed if there are any line items in subsequent 10-Qs that correlate with significant increase in pay or options of some nature to consultants? Obviously still would be speculation without knowing what it's for, but maybe another clue.
Only NWBO? Complete nonsense.
Every OTC biotech saw the same exact dip. Here's one example with $ENZC:
https://drive.google.com/file/d/1XO3O6f6JTDsCt73UZbLwxOA3vMOrEdiA/view?usp=sharing
The only thing that's a lie, is this post in it's ENTIRETY. What are you stating is fraud and a scam. Explain HOW, precisely how you think that:
-Linda Liau is in on a scam
-Dr. Ashkan is in on a scam
-All Clinical Trial Sites (MD Anderson, U Penn, Harvard) are in on a scam
-MHRA is in on a scam
Your post is a complete joke.
VikingInvest, your post reminds me of an excerpt I read when I was researching about the clinical trial data analyzation/publication process:
Thank you for the example. Wasn't there another prime example with another biotech that someone posted? Like Amgen?
Big buy at .92 to break that wall down.
Good on you Spartex. Awesome play. I am also grateful in a similar manner. My wife & I got married in July and of course I had to sell a chunk of shares. This period has given me time to reaccumulate most of them back.
The irony is that the silence IS in the best interest of the shareholders. See:
Some Sunday night thoughts on $NWBO silent period. The best analogy I've heard is that it's like Muhammad Ali using the ropes. Leaning back and taking body shots, painful but avoiding potentially even more disastrous blows that could him on the mat. In this case, NWBO is.. (1/3)
— KnowWhatYouHold (@KnowWhatYouHold) November 22, 2021
Alexis - I would caution putting extreme amounts of weight on specific quotes as we tend to apply our own narrative, mostly subconsciously, to what we hear in these conversations with Investor Relations. That said, I do believe it get be logically deduced that we are in the peer review stage and that the company is likely unblinded. Most here are relatively confident in a positive TLD, but from a multitude of various reasoning.
My sentiment as well. No pun intended.
It's likely that the example was from during data lock. I do see on the side of the page I wrote data lock, so you're likely right on that. It was a 45 minute conversation so I'm probably stepping over myself here.
So, I have direct clarification here from conversations with the company. The idh mutation status is being gathered for the publication effort as one of the experts on the review team said this information is absolutely paramount to the scientific community. I'll go back through my notes tomorrow because I wrote this one down
This is what I understood and was my interpretation as well Redneck.
I'll share what I'm talking about when I get home. I'm thinking I'm confusing celsci with one of the other failed trials in recent years.
I apologize for not stating GBM specifically. I thought one would assume GBM but forgot that we're dealing narrative twisters here. I know nothing about the head&neck specifics.
This is very inaccurate. If you want to do some real DD Kunt, go back and compare the results from the CelSCi trial to the historical control arm that is being used for the DC-Vax trial. And you'll notice that DC-Vax passes with flying colors and CelSci's treatment fails significantly.
Now that is a good fact to take away.
Happy - while I agree on the obligation to keep the shareholders informed, we have to acknowledge the target that NWBO has on it's back. We also have to acknowledge the reason behind the target and the great degree of groundbreaking potential that this treatment has on the standard of not only GBM, but all solid tumor cancers.
I have not always understood this, but as a shareholder I want them only focused on covering all bases to ensure that when they get in front of those regulatory boards we are not being delayed even further to go back and address additional questioning. I don't want them focused on the potential ambulance chasers or any of the potential liabilities that are created by sharing data too soon.
I don't disagree that they could be doing a better job keeping us informed, but the answer is already out there on what they are doing. I can't imagine the frustration that many of you that have been here 5, 10, 15 years invested feel right now. But the reality is we are here. Silence is golden for them right now. They have made it clear that they are only interested in stating facts. And when that publication is ready in a very major, impactful top-tier journal, we will be the first ones to know. I'm excited for that day, whenever it may come, and I'm confident we're close.
Laughed at the Stockholm syndrome reference.
I think the history of LP being attacked in the earlier portion of the trial because of releasing information too quick and then having to spend years fighting lawsuits is what is driving this quiet period. I believe directly that they only want to release absolute facts and ensure they're considering all angles. I'm sure they are also struggling going back to some of clinical trial sites and gathering some of the significant information learned during the trial; idh mutation status for example.
Hang on for a little bit longer. I think we will all be pleasantly surprised in coming weeks and months.
If I were to really believe that, I would sell my shares and move on.
Absolute nonsense, go find something better to do.
The idea that LP made millions from that deal is completely untrue and unfounded. And also not the case with Advent.
You know I was one of the many that built and likely fed the narrative of NWBO presenting at SNO, with blinders on to what is very obvious to me now. If NWBO was planning on presenting at SNO, they would want EVERYONE and their mother to know about it. There is literally no reason for them to hide that information in the manner that we were assuming.
It is now obvious to me that when NWBO is planning to present the data, which we all know is great data, the entire world will know about it. I'm bulletproof confident in that. It was foolish of me, whether out of hope/impatience/frustration, to assume otherwise.
Alrighty.
Laughing out loud right now. Good one Pump
Flip - check your private messages.
Yeah. I'm having the same struggle. If only they used the Dewey Decimal System
Laughing out loud at dojo's universe. Kind of like the upside down world in stranger things
Ex - how about for the first time in your history of posting here you go out and provide a fact-based reference supporting for your nonsensical statements?
Hint: You won't be able to because you are full of it.
But a suggestion if you are able, go find a comparable trial that meets these requirements:
-15 year long trial
-331 patients
-86 trial sites spanning 4 countries
-Targeting 4 RAs for approval
-Small biotech company <20 people
-Disruption to the SOC for a rare incurable disease
-Trial conclusion at the height of COVID
If you are able to find something that matches those requirements, I'll happily say "GREAT DD and Great Point!"
Hint, you will not find anything closely resembling the complexity & challenges that NWBO is facing.
I've been using my time over the last few weeks to build up some personal knowledge on the clinical trial process, the average time to deliver and came across some great research papers on the subject. I hope to enlighten some others on this board as well, but in summary I do believe that NWBO is not out of the jurisdiction of reasonable timeline here, even not considering COVID. Still without considering COVID, there are facts that also need to be considered:
-The trial spans 15 years: Think of all of that has changed that makes the analysis more complex; IDH mutation status, pseudo progression, to name a few.
-86 sites across 4 countries: Consider all of the clinical staff involved, communications across time zones, supply chain difficulties, etc.
-NWBO's company size: They are 18 or so staff, with the help out of outside consultants trying to put this all together and do it in a way that will result in definitive success. Within a lot of the clinical trial timeline research papers I've read, I've noticed that the data samples of average time to data release are only taken from the large enterprise biopharmaceutical companies that would have almost unlimited resources & much more concise/efficient processes & experience on the matter; so I do think some consideration has to be applied here.
Now once you can consider the challenges above, let's factor in COVID on top of that. I believe @iwasadiver's post from this morning is incredible perspective of the chaotic downstream impact that COVID has caused in ways that we all can't comprehend because we're not on the inside. Personally I can comment on this too as I run a 100+ IT team for major healthcare organization in the midwest. We have missed deadlines on just about every project in flight because of various issues with supply chain. For example, we cannot get new hardware; I am literally cobbling together whatever we have to continue the organization's operation.
Now for the education piece; I've read numerous research papers & publications over the last few nights and one of the most informative in my opinion was this piece released by the National Academy of Sciences: 'The Clinical Trial Lifecycle and When to Share Data' https://www.ncbi.nlm.nih.gov/books/NBK286004/" rel="nofollow" target="_blank" >https://www.ncbi.nlm.nih.gov/books/NBK286004/
In this piece, their recommended timeframe for data release is within 12 months and publication within 18 months. We know that NWBO is working on releasing both the publication & data together, and we are only on day 409. While I am one of the investors impatiently waiting, I think we need to give NWBO leadership some room to breathe here.
To further this point, and this is where I know I am injecting a bit of speculation, but I do believe that NWBO is likely involved in the Real Time Oncology Review (RTOR) program, which will greatly accelerate the approval process: https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review
Let's look at the requirements for a second:
1.
Thanks for clarification.