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$1.50 is the new $1.80 until topline.
Could possibly say we met primary, secondary and others along with subset benefits like IDH and methylated, etc. Should be a very different PR based on what we already know.
Should not be down in sympathy with an unrelated therapy, IMO. I bought too early today at $1.59 thinking our move would continue and the CVM news might actually help. Oh well, waiting for our binary anyway.
"at the latest"......wish we knew that to be 100% true.
It's a preview into what a binary event looks like! I hope our day of reckoning is in the other direction!
Opened and halted again on CVM. Down $7. Imbalance favoring downside, let's see how far it goes. Can this help NWBO? Following these results with multiple endpoint wins?
nwbo getting hit and trying to push it below 50dma. If it holds, I think we pop up over $1.65.
I am confident our readout is much more solid. 23.1 months will grow once separated placebo and treatment come to light. Then the crossover will show benefits, but likely not as robust given the later treatment start. OS will be the big number, IMO. Undeniable and approvable.
CVM halted again.
yes, down over $2.
Looks like a small gap up opening. Continuation of Friday close above 50/100DMA's. Trend change in play and small resistance at $1.65. Hopefully a good week moving up!
True story.
Apparently, once all data is collected, the CRO parks it all in tables per the SAP and then officially locks it. So, July 24th, plus a couple weeks would be trial completion date (no more data allowed). Then after compiling all data from all sources into the tables you get official data lock, Oct 5th.
It is what it is, unfortunately. Without sustained buying we get walked down on low volume. Without news we don't get sustained buying.
I'm sure there are supposed to be teeth to it. But, everything is open to interpretation, especially with the covid-delay excuse everyone can use. I hope they don't. I did ask if they apply for an extension, would they consider that a material event. No response on that one, although I did get a "breadcrumb" to my question on the official trial completion date. I referenced the July 24th, 2020 PR and was told I missed something and to read paragraph 5. That paragraph stated that the 3rd party data collection would take a couple more weeks. So, that's where I come up with August 11th for topline!
I predict topline on 8/11/2021. Just a few days before end of 1yr trial completion.
And we usually don't move up .05 on 350k shares. Hopefully selling is done, now oversold and we can repeat the process...back up, try to hold and get pounded down from a new high. Vicious cycle until news.
Interesting. Certainly fits into the both sides of the pond strategy. LP has been focused on Advent/Flaskworks/Sawston more than I would have expected prior to topline. I am sure there are behind the scenes discussions and plans tied to their certifications for Sawston. Wouldn't make sense to spend the time and money on the if-come, which tells me they are pretty confident in the data.
Danish Dude posted the August PR from last year which clearly states the trial completion date. That is what I believe to be our topline date, or prior to by a few days. If they request an extension and are granted one, I believe that would be considered a material event and need to be disclosed. I think they are scrambling to get the peer-review done on Journal piece so that it can follow up mid-August topline. Waiting for Journal review would not be considered a valid reason for delay in submitting data, IMO.
Correct, this was the PR date so I believe the true trial completion date to be a few days prior to this PR, mid-August.
I know exactly what I’m talking about. Yes, I have read the submission rules and nwbo is supposed to follow them. But your date is wrong. July 24th, 2020 was not the official trial end date. Read the PR again. Official date is at least two weeks later, or more. How do I know this? I asked.
7/24/2020 was not trial completion date. Sorry folks. The true date would be somewhere between 7/24 and 10/5, 2020. I would guess maybe 8/10ish as actual completion date based on the 7/24 PR.
The link in the pdf goes to the July 24, 2020 PR...that is no longer valid after they changed course in Oct 5th PR.
Interesting but a lot of opportunity to extend or push to two years.
Not sure I would call it ignorance. Many here know there is likely success on one or more endpoints and that this could be new SOC. The problem is opportunity cost. We have no idea where we are or what the plan is. The mismanagement of this process by NWBO with public statements and PR's only to change the process and go dark for 8 months is why people are selling. For some, there is doubt they will ever see this through. It's a legitimate concern, and caused by LP and her choices.
Yes, but the 80% reference I posted refers to the percentage who received a benefit, not the percentage who received DCVAX. Big difference.
Since Danish Dude was getting pings regarding website edits I have been checking. However, I don't know what is new or not. This may have been there for a while, but I do not remember seeing this?
https://nwbio.com/dcvax-technology/
"Most cancer drugs only achieve clinical benefits in a limited percentage of the patients with the type of cancer being targeted (e.g., 25 – 30% of the patients). In contrast, DCVax has achieved clinical benefits (i.e., longer delay in disease progression and longer extension of survival than with standard of care treatment) in over 80% of the patients who have received DCVax in clinical trials to date. Since DCVax is made with biomarkers from the patient’s own tumor, it is automatically tailored to targets that are present on that patient’s cancer.
The DCVax technology is expected to be applicable to most cancers, and is embodied in several distinct product lines. One of the product lines (DCVax®-L) is designed to cover all solid tumor cancers in which the tumors can be surgically removed. Another product line (DCVax®-Direct) is designed for all solid tumor cancers which are considered inoperable and cannot be surgically removed. We believe the broad applicability of DCVax to many cancers provides multiple opportunities for commercialization and partnering."
It does matter. Just by saying "we are close to the finish line" tells the story. No One knows that. And, there is no way to estimate the timeline with zero info from the company. Period. It could be tomorrow, it could be next year, or they could choose to never produce the results in a topline form.
Yeah, LOL. Says the person who has been here for a month. If you have watched LP's antics over the past 6 years, like I have, you may not have as much patience.
256 days since data lock and not a peep about when we will see topline That's why we tread water and head lower again. Oct 5th PR? Please. "Coming months" Ugh. I believe there is plenty of information they could give us for updates and they choose not to. Which of the 6 process steps are we in?
How many are still alive? When was the company unblinded? Why haven't they changed the clinical trials website? Anything.
Would hope that by reading those tea leaves that LP isn't stupid or desperate enough to make that deal without knowing she would be able to repay. And the ability to repay would mean revenue. I certainly hope that's the case.
Ashkan is not one of the lead investigators and may not be included in unblinding. Linda Liau is principal investigator and Bosch is is study Director. Ashkan was included in the previous Journal article as author/reviewer but doesn't mean he has to be included in data review.
Based on the last $11M loan terms, NWBO was certainly hoping to be generating revenue at Sawston by November. And, it wouldn't be from a sudden approval of DCVAX prior to November, but at least the UK Specials programme and maybe compassionate use in EU.
I hope you are wrong as well. I also do not believe summer has anything to do with release either. That is not a thing in the US. If it's ready and Journal has the green light I believe they will get it out there asap.
You are correct. There is nothing stating Sawston has anything to do with topline release.
I agree. We should have data by now. I am not as confident in LP's strategy as most here are, and have disagreed with it all along. FDA approval process on good data is another eon away, IMO. Let's just see the friggin data first. I can wait another year for the FDA if we are sitting at $10 a share fending off buyout offers.
I would not doubt a September topline but I do not think the release has anything to do with Sawston certification, or they would have said so. They have stated multiple times that the Oct 5th PR is what they will deliver. Topline and Journal. The delay has been the unblinding process and covid delays, multiple party reviews, and I believe now, Journal peer reviews.
These days it looks like the next news might be the next 10Q, which would be August 15th. We are approaching 200 days post-data lock. I just can't understand why we can't get an update on where we are. I don't see a negative even if they don't say potential dates. Even just how many of the step have been accomplished? It would mean we are closer, it would mean we will actually see topline at some point. Right now all we get is "we are working hard to get to the finish line." That, in my opinion is why we aren't higher with PPS. Because there is still potential for "never." An update would dispel the FUD of the AF's of the world.
Any mention of DCVAX in the article? I have the link but am not a subscriber. Thanks.