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Knowwhatyouhold.com
TLD 3/2022
Excellent post DD. Can't wait until your global victory tour.
26 years to bring this innovation forward. The whole NWBO team deserves purple stars!
This is 100% on point bio in my mind. Thank you for your logical, unemotional posts.
Very well said and very interesting. Thank you for sharing CapHillGuy.
Laughing out loud. Thanks TDD
I didn't ask you to agree. Just sharing my opinion. Respect yours as well!
I believe things like biomarkers, idh-mutation status, and likely other technicals that were newly learned over the years, and were not recorded in this available data and they are having to reach back out to the clinical trial sites where these historical trials were conducted to get the additional data from the physicians and/or tissue samples from the patients.
Redneck, I'm not certain what you ask. We know the SAP is already amended:
"The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma. This endpoint will be assessed using 3 different analyses"
The details of these comparable "historical" trials are what are going to make the dc-Vax data irrefutably ground breaking in comparison.
That does not apply to the publication Mr. Home Depot. I believe the additional layer of information they are assembling is for the publication to cement & reinforce the ground breaking results.
Yes, but this has nothing to do with my message. I'm stating that this delay of TLD announcement has nothing to do with manufacturing certification or Flaskworks approval. In other words, the two are not interdependent in any way, shape or form.
Exwannabe, respectfully I would love to hear a rebuttal here.
What typically happens is that you just move on to the next narrative and then restart this same argument in a couple of weeks.
Let's finish this one... otherwise I will assume you're just taking advantage of the sale of shovels at home depot :)
I strongly believe that the hold up is related to assembling the historical "placebo" control arm data and this is what is specifically causing the time delay.
I do not believe this has absolutely anything to do with Flaskworks or any manufacturing approval. The company has not once indicated that in any PR statements. Nothing in my conversations with the company has ever alluded to that being the case.
While I wish the company could provide a status update and more specifics about where they are in the process, I think it's quite a bit more straightforward to read than we anticipate. Occam's razor.
Go with cereal.. Lucky Charms specifically ;)
Yes. This is actually something that I've spoken about with DI on.
Good call out and reminder @reachjo.
Well said and aligns with my sentiment ATL. You were on fire today.
I do not believe a presentation is in the mix. I believe that they are still finalizing the data and patient records of the placebo arm based historical controls and that is directly the hold up.
It would be helpful if NWBO came right out and said that, but I don't know what repercussions that would have if they did.
Sojo's posts are based on technical charting which can be highly accurate when there is consistent higher volume.
Since we are not trading anywhere near high volume, it becomes very unpredictable. The MMs and manipulators or whoever with the most money, can take the stock price wherever they want it to go.
Further, his predictions and charting is based on the current trend lines being formed, so they are accurate at the time he shares them; but when those trend lines break, or we lose support at a particular price, then the chart analysis is effectively reset.
P.S. - Keep doing what you're doing Sojo. I appreciate your posts and have learned a lot from your charts.
I don't fully disagree with that statement, but they still need to be able to prove their technology to scale and that matters to potential BO suitors or partnerships.
TLD will come. And then it will matter if we can scale up vaccine creation for RA approval, so in the bigger picture to reach maximum SP on RA approval, it matters very much.
Flip - these are my exact notes (and my interpretation) regarding Flaskworks conversation with DI summarized below. This conversation happened in late December of last year so I do not know how things have changed, so do not hang DI or me for sharing this:
I really do believe that Bio's sentiment that NWBO is struggling with the timeliness to assemble the placebo arm based on historical trial data (not DCVax) is the high likelihood of where this is caught up. This is also likely why Stupp has joined the NWBO consulting team to assemble this specific data. If you take a step back and think about it, why would these clinicians have incentive to 'rush' to getting this data when they have their own world to tend to. I know they all care about the patient care advancement, but they might not even know about the potential of DCvax. I do believe the world is easing up in terms of COVID and I'm hopeful that will speed up the process a bit for them.
Looking at it from the NWBO management lens, I'm sure it's equally frustrating for them as well if they're not getting buy-in from the people that hold the keys to the historical trial data they need to finalize TLD and they have all of us banging down their door everyday and can't say anything about it.
I do not believe the hold up has anything to do with really much else that has been suggested here, including: presentation alignment, journal pushback, Flaskworks certification, BLA submission, regulatory approval, etc.
I do believe however that NWBO is using this time wisely to redirect efforts to other initiatives that will fast track approval and shorten the window from TLD announcement to RA approval.
To be clear, I'm equally as frustrated with everyone here as I have been invested for many years and major % of my portfolio is tied up in NWBO, most of which has been bought in the 1.20-1.43 range - but as many have shared, I know we will be successful in the end.
Hah! Maybe news this week :) My wife's psychic might have been right on point with her 3/3 prediction!
This aligns with the other post shared with the journalist who wrote the article as well, sharing that they are indeed a direct quote: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168049071
These were my thoughts as well Viking though stated much more eloquently by yourself.
Great posts today Bio. Appreciate you and your knowledge.
Bio thanks for the quick, great response. I think what you're saying is completely reasonable/rationale and a high likelihood of being the case here. Thanks for your continued wisdom.
I wonder how much longer we truly have. I'm still holding on to the date from the psychic that my wife went to see lol - 3/3/22... fingers crossed.
Bio, I know you've been adamant about the FDA guidance being finalized, potentially being a major factor here. And I do agree with that.
Outside of the publication that was put out a month or so back where several of the authors were from the FDA; is there anything else specifically you're anticipating? Are you thinking there will be an official guidance update released?
Would love to hear your thoughts on current state and what impact you believe this has on all the timing at play.
Appreciate you bio. Hope you're well.
No - I'm saying that LC's post about Bigger visiting another company, not NWBO in Bethseda is misinformation.
It's very clear and obvious that Bigger visited NWBO and likely was exposed to NWBO's plans with Flaskworks.
I don't even pay these guys any attention. Bigger then wrote about Flaskworks having incredible potential almost immediately after his post about visiting Bethseda.
It's just another opportunity for these clowns to spread misinformation.
Don't do it flip. Give them a couple more months, May.
DMB - Previous conversations with DI in December. My interpretation of the dialogue I had with him is that they are working in a parallel workstream to perform the necessary due diligence to certify the platform and are targeting late Q1/Q2 to complete this process. I just went back and re-read my notes to confirm that as well.
I believe it will be certified in the second quarter of this year. I'll bet on it.
Thank you
Yeah - ThinkOrSwim at least gives 4x buying power when the pps of the holding is over $1/share.
Investors want to see this over $1 asap; people like Bigger, because once the price is over $1, it can be used as leverage buying power in the broker/margin accounts.
This is going to my future copy and paste:
"Hey man, sorry to bother you. I was wondering if you happen to know Leslie Clemmer at SIU Medicine. He's the executive director of IT and I'm supposed to have a call with him tomorrow. I'm just trying to get a little info on him to prepare myself. " -RH
Completely untrue and you are now placed on block as I'm sure many have already done.