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Thank you! That is indeed part of the driving factor behind the site. Will continue creating and sharing where applicable. Thanks for the kind words/support.
You didn't ask me, but there are many ground-breaking outcomes as part of this phase 3 trial's conclusion most notably:
-A change in how oncology trials are conducted in the future through the elimination of an unethical placebo group by use of historical controls.
-A disruption in the standard of care, initially for GBM, but setting a baseline for further disruption soon after for all solid tumor cancers.
These are the reasons for a peer-reviewed publication in a MAJOR, TOP-TIER (their words, not mine) medical journal.
The burden of ensuring all t's are crossed and i's are dotted in today's new covid world order (as exwannabe puts it) are a significant part of the reasons for the delay.
The end result will be alignment across all regulatory parties, the medical community, and patient advocacy groups for the perfect, irrefutable, ground-breaking treatment to change the outcomes of cancer patients world-wide.
Interesting that you just mentioned this. I've just finished up posting a summary of the endpoint changes and RA buy-in (based on @ATLnsider's great work) here: https://knowwhatyouhold.com/t/pseudo-progression-trial-design-regulatory-buy-in-evidence/21
Chicken Tikka massala is a close second for me too. There are two places where it's incredible by me. One of the most flavorful meals I've ever eaten
What's your favorite dish? Huge fan of chicken vindaloo (if that's how you spell it)
Dr. Bala - If you ever make it up to Long Island let me know! I've just started exploring Indian food and there are quite a few great places nearby. I'd happily shoot you a list!
Merry Christmas to you and yours DD
Word up diver!
Good to hear from you! Hope you and your family has a great holiday, and I hope you're off the clock!
Cheers to all of the other great ones on the board too. Merry Christmas to my IHUB family!
NWBO will:
-Drive forward reformative ground breaking & ethical improvements to how all oncology clinical trials are conducted in the future through it's adoption of the historical control arm.
-Will deliver ground breaking results that will become the standard of care for not only GBM but all solid tumor cancers.
It's so very obvious that these are the only outcomes.
Can't wait for that knowledge to drop on your head and knock you unconscious.
Last I spoke to DI, he mentioned the range of shareholders to be between 30,000-40,000.
Jerry can you then quantify what you believe to be realistic so we can all have a big collective laugh with you (not at you).
Thanks for clarifying!
(Sorry senti!)
Can you confirm where you are pulling 100% of market share out of his statement? He said specifically 12,500 and stated 1/2 the cases of EU&US which would mean 50%.
That doesn't seem too unrealistic to me.
hah - I just posted the same thought.
I think some here need to take a step back here and look at the dialogue that's transpiring here. For weeks the conversation has been about manufacturing and Sawston approval, and a whole bunch of negativity around that. Now it's come, and look at the context of the conversation - we have within 8 hours of the announcement, have let ourselves get sucked into negativity around lack of TLD! Already! This is the strategy to distract from the incredible news of 45-50 patient capacity per month. Incredible news - more lives will be sparred. Our treatment now has a greater reach!
If I were many here, I would not even feed any of the attempts to distract & create a negative narrative here. We are on the up & up now!
Let's take a couple days to celebrate this incredible milestone and patiently wait for the next incredible milestone of TLD/Publication which we know is on the immediate horizon.
Great day, great news all around. Let's go!
Strong close, some big buys at the end there to counter some of the heavy sells coming in. Popped us right above the VWAP
Lykiri how did you find this with it not being listed on the main page.
Either way, incredible job as always.
It is not related to approval in that the facility certification of does not infer RA approval.
It IS related to the approval in that it checks a very important and significant box relating to the requirements necessary for RA approval of the treatment.
Great post brother.
Lol! I laughed at this eloquent response.
Cheers to that buddy!
I don't know where we stretched to Flaskworks certification happening in Q4. When I shared this information, I explicitly stated that they were targeting certification for end of Q1/Q2.
I can't help but assume someone ran with this to setup another mouse trap.
The front page will show you all certifications sorted by most recent. All you have to do is refresh that front page. One member in the past highlighted that new certifications are post between 2-5 PM EST time.
Smokey - very well written. I have started & stopped several times in writing something very similar to this. I appreciate the framing and walkthrough. Great job all around.
I am betting on this week too. I also believe Friday's push down was in part due to a final last ditch effort to allow shorts to get out at the lowest price possible.
Great analogy and reminds me of when I walked full speed into a floor-to-ceiling glass door a few months back on my honeymoon because my wife decided to hide the opening of in the curtains because she didn't want to let bugs in. lol!
I know you didn't ask me, but I do believe we will see certification in the next two weeks. If you look at the GMP site, https://cms.mhra.gov.uk/mhra/gmp , the frequency of certifications issued has been increasing and I believe that the MHRA has moved to remote-based certifications and has not halted the certification process due to COVID increase, as seen in their most recent certifications with the content of:
"The certificate is issued based on a remote inspection of GMP compliance during COVID-19 travel restrictions. A risk-based site inspection programme remains in force."
We know from the press release issued on the subject of HTA certification, that the physical site inspection was already conducted:
"The original inspection timing was delayed by MHRA due to their caseload; however, the week-long onsite review by two MHRA inspectors was recently completed. The final phase of the process involves receiving an official MHRA inspection report and taking any responsive actions that may be required. The Company currently anticipates that this process will be completed before year-end."
Based on the likelihood of gaps being procedural & documentation based, I believe they will still meet the anticipated timeline.
Wondering does not = change.
Couldn't agree more with the entirety of this post. Kudos.
This was what i interpreted to me in my hour long dialogue with DI, which I shared previously.
I'm here to see this through to the end, like many of those here. If we are in the same exact position in 2026, a reduction or exit from my position will likely have been dictated due to changes in my personal life & priorities.
As a shareholder, no I won't be satisfied. Nor am I stating that you should be satisfied even in the current state. Investors have a right to be frustrated.
However, 5 years and no communication still doesn't dictate that anything has changed until the organization either communicates the facts and changes, or there is substantial, logical evidence of a change via another medium. That is the only way for a fundamental change to occur, which I'd expect there to be a communication from the company that would detail that information.
Look I'm not defending the companies actions other than reminding everyone that nothing in fact has changed other than the passing of time. The inference of any other narrative is just a lie.
I can't say I disagree with some of your points.
I do think there is weight to the other perspective are being very careful about what is being said & shared as to not end up in another frivolous law suit and likely because of the quiet period which will all be revealed hopefully soon.
I'm with you on the communication being better and providing more transparency. I'm with you on the disgust of looking at my investments being 50% in the red.
I believe however in the meaning of the silence of which we will understand and appreciate in due time.
That's such an illogical argument. The passing of time does not indicate something has changed. We know we are anticipating Sawston certification and are still within year end. We know we are waiting on peer review.
Until Sawston certification fails or the company updates on a failure, which we all know how small the risk is, then nothing has changed except the date on your clock.
I believe that the short push was to drive the price down and get out before next week.
Dude - I share your frustrations, but we know what we're in for here. Nothing has fundamentally changed. Data is locked, Sawston certification in progress, peer review is in progress. People can sell out or people can double down on, in my interpretation of irrefutable evidence of positive results.
If you liked the stock at 1.50, you sure as hell should like the stock at .59 cents.
Bought another 20K worth today.
I've been monitoring the social sentiment for the last couple of weeks and that was definitely a coordinated short attack to drive the price down. People are out in full force, spamming ALL OVER to create that overwhelming sense of fear.
I believe someone knows something and that we will get positive news next week. Some MAJOR volume there.
Wrong. Majority of NWBO population is actually in very low in candidates that make up the best prognosis in GBM. Just a very dumb comment.
I'd guess it's because they are busy with TLD.