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I also have a feeling about news pre-market tomorrow, otherwise between Monday/Tuesday of next week. But I also reflect back to three years ago when we were guessing which week the NEJM would be publishing the TLD.
Oh the good old days.
Regarding comments by Les, here's a little more...
"We’re hoping for very encouraging results and we’re some weeks away from having those answers"
Then the commentators said "Les, we’ll have you back later in the week or next week"
Is he a regular contributor? Or at least enough where he is on twice a week? Or maybe he referenced a follow-up interview off-air?
What about my perfect socknostication that led to this ramp in sp?
Good luck mate.
It was apparently the microcapdaily article that DI apparently sent him. Wondering if it was a single incident. I didn’t receive it. Others?
It just seems odd that he would forward unsolicited news links from third parties, IMO
Here's the soundtrack to the last two days of NWBO trading...
Speculation only... PR tomorrow aligned with kick-off of virtual ESMO providing data around primary and secondary endpoints (met or not met). It’ll serve as a trailer ahead of SNO LBCT on 11/20 by LL. Allows a slow build on so until then... with possible BO news in between. IMO
“I would think that the mere fact that they report we are still on schedule is itself very positive news.”
As the kids say... ROTFALMAO”
She actually uses the metric calendar that goes by 000’s
I do like the idea of TLD ahead of 11/20, so any questions/concerns around primary endpoints, long-tail, trial issues, etc. can be addressed at SNO.
Dr Bala - how do you think it gets presented?
My med device experience has been that if LBCT is planned, nothing is announced until the morning of the presentation. A press release is usually embargoed pre-market with basic info, i.e. met primary endpoints, and then the details of the study design and some quotes from people like LL, MB, and LP... then the full study presentation will happen as schedule. That provides the most buzz and coverage.
TLD in September (or even October) is hopeful thinking, but when we are down to months/weeks, they aren't going to feel rushed. They also want to time accordingly with headlines (i.e. election hype).
Agree. IMO, I think LP confirms data lock on 9/12 and will point to 11/20 for TLD presentation.
Where is Sushi?
My apologies as I know this is deep in the message board, but when is LP presenting this month? Was it Sept 12th? or 21st?
LL’s cancellations seem to align with great events for the day. PR released before market, then LL hits the media circuit. Then plenary session, followed by more media. And they would only have that much coverage of it was positive news, IMO.
Linda is presenting on 9/12 and am I certain that she has had a chance to peak at the TLD. I can't imagine why you'd want to publicly say ANYTHING in the window of time between her review of TLD and actually release of TLD, IMO
Unless she plans to release TLD then, with a full presentation on 11/20.
What about my socks?
Howard Roark? Shall we meet in the gultch at the end of September?
Doc... I’m not even slightly kidding when I say that it was probably one of the most perfect tosses I’ve made in my years of sock tossing. Like a diver entering into the water with hardly a splash.
Thought about tossing again this morning but restrained myself as I didn’t want to look a gift horse in the mouth... and look at the horse we got!!!
Doc - I’m going to miss your posts when all of this is said and done. Thanks for allowing my levity.
Thanks to you both Sojo and Doc. It’s been a fun journey and have appreciated you along the way.
If TLD is positive and NWBO submits to the FDA ASAP, what are the odds that Trump pressures Hahn to approve DCVAX before November 3rd, so Trump can say he cured cancer?
Welcome Fish2020. Sounds like someone needs a socknostication.
Happy September everyone!
Apologies Doc. Immediately after our last exchange, I walked back into my closet and grabbed a pair of socks. I kid you not, but
I had a perfect toss... hit the second step and landed on the first step in the most preferred sock landing fashion. Little movement or shifting. Rested easily and quickly. And quite honestly, was the most forward “I want to land on the first step so solidly”. Doc, you would have been proud. So let’s parlay that into great news in the next 14 days.
Be well my friend!
Doc.
I apologize.
Two versions of a bank tomorrow. I promise to detail to details of the details.
I’m on it Doc!
I totally forgot that I muted Scotty until you reminded me. I’ve really been enjoying myself.
Dilusion, dilution, dilution until SP was under a dollar and Nasdaq delisted NWBO.
Wasn't that Hank?
Captain, let's be honest, as a high schooler, you were just proud that you finished a 1,000+ page novel.
what's with the run of "911" trades that just happened?
Commercial media has limited bandwidth. And let's face it, it's more fun to mention that the bipolar presidential "candidate" Kayne West's brand Yeezy collected between $2 to $5 million in PPP.
Not to mention the billionaires, country clubs, and private jet companies.
Geez...
https://www.thegreatcoursesdaily.com/government-grants-loan-to-libertarian-based-ayn-rand-institute/
That's actually pretty funny!
Are you serious? Would that be a true example of irony? Ayn would be spinning in her grave.
Who is John Galt?
I said it a long time ago... DL is a binary event that won't produce a significant price increase/decrease. For those that were saying that the price would jump from $0.40 to $1.00, what happened?
As I post this, it's down 3%.
AND today is Friday, July 24th, 2020.
If you have Investor Relations questions, call or text David Innes (PH: 804-513-4758) and request an update to previously communicated timelines for DL and TLD.
It’s July 23rd, 2020.
Call or text David Innes (PH: 804-513-4758) and request an update to previously communicated timelines for DL and TLD.
From the April 18th, 2020 Press Release:
https://nwbio.com/nw-bio-to-discuss-projected-schedule-for-data-lock-unblinding-and-top-line-data-from-its-phase-3-clinical-trial-at-annual-shareholder-meeting/
“The Company believes it can reach data lock by approximately the end of May.”
“Based on [their] expectations, and taking account of the two months lost in March and April, the current estimate of public disclosure of top line data would range from the end of June to early July.”
It’s July 23rd, 2020.
Articulated NWBO timeline:
DL = End of May
TLD = June to early July
It’s July 23rd, 2020. (DL milestone was missed; TLD milestone was missed).
Call or text David Innes (PH: 804-513-4758) and request an update to previously communicated timelines for DL and TLD.
From the June 2nd, 2020 Press Release:
https://nwbio.com/nw-bio-provides-update-on-projected-timing-for-data-lock-for-phase-3-trial-of-dcvax-l-for-glioblastoma-brain-cancer/
“In light of the current status of the completion process, and the experience over recent months, the Company currently anticipates that the process [final data collection, identification and resolution of queries, data checking and confirmation, and site sign-offs] may be completed by about mid-June or shortly thereafter – i.e., within a couple of weeks after the Company’s anticipated schedule at the time of the Annual Meeting in April [April 18th, 2020]
“If some of the information that currently remains outstanding cannot be obtained by mid-June, the Company may consider proceeding with a “soft lock” of the data at that time, if arrangements can be made for the rest of the data to be included when it is obtained later.”
“It is too early to determine what effect this update of the anticipated timing of data lock may have on the anticipated timing of the public announcement of data. There may be a similar update to the timing of the announcement of the data as to the timing of the data lock.”
“Initially following data lock, only the statisticians will be unblinded (i.e., will be given access to the database containing all of the raw data from the trial). The statisticians will need several weeks to carry out all the relevant analyses and calculations. Then the statisticians will deliver the results to the Company, and that is when the Company will become unblinded. The Company will then discuss the data with key advisors, such as its Scientific Advisory Board and the Steering Committee of the trial, and will address any comments or questions from its advisors as part of preparing the data for public announcement.”
“If the anticipated timing becomes significantly different than currently anticipated, the Company plans to provide additional update bulletins.”
Articulated NWBO timeline:
DL = Changed from End of May to mid-June or shortly thereafter (soft lock) – therefore, DL milestone was missed.
TLD = Changed from June/Early July to after soft lock + unblinding statisticians and carry out analyses (“several weeks”) + deliver/unblind the company + discuss with SAB and SC and address comments/questions (IMO, ~4 weeks) thus deduce latter half of August.
It’s July 21st, 2020. (DL milestone was missed; TLD milestone is now officially missed). Company has not provided any additional update bulletins”.
Call or text David Innes (PH: 804-513-4758) and request an update to previously communicated timelines for DL and TLD.
It’s July 23rd, 2020.
News coming tomorrow or after-hours today?!?
Remember on July 1st when you said:
"I bet data lock news either today or tomorrow. And once the data is locked, immediately the computer spit out the trail success or failed, I mean Endpoints Met info. The details to iron out everything takes time. If they miss it, it doesn't mean incompetence if they are waiting on the last IDH slide that that site is kind of not that cooperative due to Corona. Can missing IDH info can be added after TLD? It won't change the TLD, but is it allowed? Meeting the criterial - Does it mean incompetence? BSB is full of BS."
Do you also think DL will happen August 14th?
It’s July 21st, 2020.
From the April 18th, 2020 Press Release:
https://nwbio.com/nw-bio-to-discuss-projected-schedule-for-data-lock-unblinding-and-top-line-data-from-its-phase-3-clinical-trial-at-annual-shareholder-meeting/
“The Company believes it can reach data lock by approximately the end of May.”
“Based on [their] expectations, and taking account of the two months lost in March and April, the current estimate of public disclosure of top line data would range from the end of June to early July.”
It’s July 21st, 2020.
Articulated NWBO timeline:
DL = End of May
TLD = June to early July
It’s July 21st, 2020. (DL milestone was missed; TLD milestone was missed).
From the June 2nd, 2020 Press Release:
https://nwbio.com/nw-bio-provides-update-on-projected-timing-for-data-lock-for-phase-3-trial-of-dcvax-l-for-glioblastoma-brain-cancer/
“In light of the current status of the completion process, and the experience over recent months, the Company currently anticipates that the process [final data collection, identification and resolution of queries, data checking and confirmation, and site sign-offs] may be completed by about mid-June or shortly thereafter – i.e., within a couple of weeks after the Company’s anticipated schedule at the time of the Annual Meeting in April [April 18th, 2020]
“If some of the information that currently remains outstanding cannot be obtained by mid-June, the Company may consider proceeding with a “soft lock” of the data at that time, if arrangements can be made for the rest of the data to be included when it is obtained later.”
“It is too early to determine what effect this update of the anticipated timing of data lock may have on the anticipated timing of the public announcement of data. There may be a similar update to the timing of the announcement of the data as to the timing of the data lock.”
“Initially following data lock, only the statisticians will be unblinded (i.e., will be given access to the database containing all of the raw data from the trial). The statisticians will need several weeks to carry out all the relevant analyses and calculations. Then the statisticians will deliver the results to the Company, and that is when the Company will become unblinded. The Company will then discuss the data with key advisors, such as its Scientific Advisory Board and the Steering Committee of the trial, and will address any comments or questions from its advisors as part of preparing the data for public announcement.”
“If the anticipated timing becomes significantly different than currently anticipated, the Company plans to provide additional update bulletins.”
Articulated NWBO timeline:
DL = Changed from End of May to mid-June or shortly thereafter (soft lock) – therefore, DL milestone was missed.
TLD = Changed from June/Early July to after soft lock + unblinding statisticians and carry out analyses (“several weeks”) + deliver/unblind the company + discuss with SAB and SC and address comments/questions (IMO, ~4 weeks) thus deduce latter half of August.
It’s July 21st, 2020. (DL milestone was missed; TLD milestone is now officially missed). Company has not provided any additional update bulletins”.
It’s July 21st, 2020.
Or Sock Toss Day
Covid + Summer... haven’t worn socks in 4.5 months...
Might need...
National Flip Flop Toss Day