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Sept 28th will mark 30 days since the PR. Assuming they submit the MAA right on the 30-day mark (and not earlier), we may hear something by Oct 3rd (Tuesday Newsday).
Worst case scenario, they submit on the 45-day mark which lands on Friday, Oct 13th (spooky). In this event, we may hear something by Oct 17th (Tuesday Newsday).
My personal expectation for submission/acceptance news is Oct 26th, which takes into account the longest possible time frame for news, plus a week or two.
My gut feeling is we will hear something by the first week of October.
Bid/Ask at .84
PPS may pop up early morning for a bit.
Negative, mine was smooth.
This man has the ability to see 15min into the future.
Amazing.
Gotta love the EOD selling
Absolutely
6000, or 60,000?
The fact that they specifically included "active discussions" in the recent 10K tells me that we will have partnerships soon.
Hopefully we'll hear something within the next month on that.
Aug 28th submission anticipation? Could also be oversold and some jumped back in.
Perhaps they are treating multiple filings as "one application".
Double that and I would probably be ok with it.
Maybe.
End of August looks to be when submission will likely occur.
REALLY hope it does not go beyond that. Looking to be a late 2024 Q1 or early Q2 approval.
10Q Highlights:
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001072379/000141057823001633/nwbo-20230630x10q.htm
In June 2023, the Company presented substantial information from analyses conducted by independent experts on the underlying biology and mechanism of action of its DCVax technology at an Industry Theater presentation during the ASCO (American Society of Clinical Oncology) conference. The Company is pursuing further analyses by independent experts, and plans to present further information at an appropriate future conference.
The Company is now in the final stages of preparing an application for regulatory approval of DCVax-L. The Company is working with teams of specialized consultants on preparation of the application package as well as related activities. One of the pre-requisites - obtaining regulatory approval of a Pediatric Investigation Plan (PIP) - was completed during 2022 on an accelerated basis, including regulatory approval to use the same trial design with external controls as was used in the Company’s Phase 3 trial.
The Company and the CRO continue to conduct long-term follow-up in connection with the Phase III trial of DCVax-L, as there are still patients alive.
The Company and Advent are working together to prepare for potential commercial operations. The buildout of Phase 1B of the Sawston facility, which had been under way since last year, has been completed. On July 24, 2023 the Company changed the name of its UK subsidiary from Aracaris Limited to Northwest Biotherapeutics Limited.
The Company’s wholly owned subsidiary, Flaskworks, is continuing its development work to optimize a system for closed and automated manufacturing of DCVax-L products, including optimizing yields. The Company views this as a centerpiece of efforts toward scale-up for potential commercial operations.
The Company is in active discussions in regard to certain combination treatment regimens, and is planning for certain strategic trials with such combination treatments.
In the future, we plan to conduct clinical trials of DCVax-L for other types of solid tumor cancers, beyond brain cancer, when resources permit.
Anything else important from the 10Q? Or did you just immediately dash to that section to spread FUD?
Just spit-balling here:
Assuming the company is intentionally leaving us in the dark, wouldn't that go against their fiduciary duties? Let's assume they have already submitted month(s) ago, but the next 10q on Aug 14th states that they are still in the process of finalizing. Wouldn't that be a bit of a smack to the face on investors?
Granted, things could be much further along in the process without submission happening, but this potential information of progress would be beneficial to us as the timeline has dragged on longer than what was anticipated.
I see two scenarios:
1.) (UNLIKLEY): NWBO is farther along than what is currently known. Submission could have happened already. Thermo's and Les's remarks was made to throw off nefarious forces. Acceptance and/or approval is in the works. (Canadian Drug Bank's update back in March may add some small credibility to this theory.)
2.) (LIKLEY): NWBO has not yet submitted. Les's talk on the Big Show and Thermo's comments hold merit on filings being finalized still, and the Canadian Drug Bank's update was just a routine manner for anticipated drugs coming out of Phase 3 trails that may or may not get regulatory approval (my assumption).
Hoping we are all surprised with approval news (or something in between), but IMO, it's looking as if we are still waiting on submission. Aug 14th's 10q will tell us more hopefully.
TDD, from what we gather we have not submitted yet.
Are you insinuating that we are much farther along, and perhaps already submitted? Contrary to what Lez Goldman on the Big Biz podcast stated?
Thermo, you don't owe us anything. Regardless, we do appreciate your insight on things.
Majority of us are just restless, so take the grumblings with a grain of salt.
If NWBO does in fact submit in September, then the 2024 Q1 & Q2 approval timelines some have given would actually be accurate.
Really hoping we submit and get approval sooner than this.
Why has this board committed to "eating their own" as of late?
This is exactly what the "shorts" would want. We need to cut back on the infighting and get back to the basics of NWBO.
I really hope the September prediction is wrong. In my opinion, this process is taking entirely too long.
Obviously, I want it to be correct and accepted/approved, but eventually they need to pull the trigger.
Any comment on the data he presented, or did you just cherry pick his "generational wealth" comment and roll with that instead?
Especially if there is a backlog of patients waiting for DCVax-L. It'll take time for present patients to receive treatment when many others have been waiting.
What changed in the TOS?
I'll bookmark this post and come back to it when we submit soon ;)
Canada Drug and Health Product Submissions has updated to their latest submissions for June 2023. NWBO is not on the list yet.
Hopefully July or August we'll see NWBO, assuming they submit within the next 4-5 weeks.
https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html
Yea...she's pretty strong on her political beliefs.
We need to submit first. Hope Annie doesn't think approvals are a month out. She has a tendency of being "optimistic".
Really interested in the X number of patients that can be treated when Flaskworks is running. Hard to imagine we would be able to treat 1 million patients a year, let alone 4 million.
Not impossible though.
Is 1.7 million pages typical for a specific drug approval? Also, if we are not granted rolling review, could approval be a considerable ways away with these many pages and modules?
May not get one until the next quarterly report unfortunately.
If we haven't submitted for MAA by then, that's when I'll start to get antsy. Would rather have approval before September if at all possible.
Me neither. We'll find out soon hopefully.
Some more speculation:
Perhaps the $3 Million pre-payment was awarded from a BP due to an MAA submission, and upon approval details will surface about the contract.
Added another 5000 shares. Waiting on submission/approval now.
Early day today due to holiday tomorrow.
What is with that trading pattern from 1:30 to 2:30?
Same here. Losing Level 2 functionality was a bit of a disappointment.
But hey, for $50 a month IHub will give you L2. Great deal, eh?
*Sobs*
More context to this post:
I did say I disagree. And I discussed it with him afterwards. You wouldn’t believe which article he referred to as his “proof” that dcvax trial failed. A lot of doctors saw that article before reading the Jama article and it clouded their judgement.
— Al Musella (@AlMusella) June 21, 2023
It appears Squire’s didn’t have the info needed, or was properly prepared to update financials in a timely fashion. No other reason to lag behind so late for such a small company.
My theory is he’s running out the clock so that if/when he does file, he can start fresh and forgo years he couldn’t file for.