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No. Prior articles indicated he was undergoing radiation treatment and the melanoma treatment from Merck called Keytruda.
More recently in October she indicated the current estimate for reaching the primary end point is September/October 2016.
The following is a list of events I've pieced together (mostly from your posts) that may be part of what we will call a likely scenario (among several). Please review when you have time and let me know if I missed anything.
The 1st IA occurred around June/July 2015. The results were statistically significant enough to warrant a DMC recommendation for regulatory review, but it was necessary to wait until the number of patients enrolled/screened reached a number where full trial enrollment was 'reasonably expected' to be attainable from the pipeline.
The enrollment/screening requirement occurred in early August and the screening suspension was implemented.
The regulatory information (AA/BLA application) was filed in mid September.
Full trial enrollment may have been reached at the end of October (as indicated on the .gov status change). They have not announced it due to the close proximity of the 1st IA and regulatory filing and the conclusions that could be drawn if everything were PR'd. Or, enrollment has not been officially completed, but the last patient will begin first treatment in the next few weeks.
They are currently working with regulatory agencies through rolling review, and are awaiting a 74 day response that may occur any time between now and the end of February.
Makes sense. Thanks
Going back to the question of announcing the full enrollment status. I still don't see how this would assist anyone in modeling. They didn't announce when the 1st IA occurred, they don't have to announce when the 2nd IA occurs. Everyone is expecting top-line results by the end of next year at the latest.
Because of the wide variability in enrollment pace over the years, I just don't see how this extra piece of information would provide a missing link in modeling the length of PFS or anything related to OS. Maybe I'm missing something. Also, it seems in my limited experience that companies commonly announce full enrollment status.. It makes more sense to me that the trial hasn't 'officially' reached full enrollment (some of the pipeline patients are still somewhere between screening and first treatment).
That's a reasonable way to look at it. But if that's the case, I don't know why Linda would even include the "plus about a month" comment when she did. Just leave the expected timeline of "end of Summer 2016" that had been previously stated and make adjustments to the timeline down the road if/when screening is required to resume. Not making the comment makes more sense to me under your scenario, especially since she has been so committed to err on the side of silence.
I've also considered the possibility that the one month comment is more applicable to a worst case scenario where the pipeline patients were insufficient to reach full enrollment. Such as if a higher % than expected failed the final criteria to begin treatment. Thus it really represents the amount of time that would be necessary to recruit/enroll a few more to reach the 348 (based on enrollment pace at the time of the screening suspension).
"If the interim analysis already occurred and AA is being sought," - Flipper
Is this still the most likely scenario IYHO? Thanks
I'm still a little baffled with the question as to whether or not enrollment is complete. The idea that the temporary screening halt was just a normal expected step once enough patients were identified to exist in the pipeline doesn't seem to jive with a "temporary" change in screening or with the 8-k filed in October that includes a revised timeline to include "plus about a month of cushion to take account of the temporary hold on new screening for the trial as we announced in August." If this were normal progression to full enrollment, why would it result in additional time to trial completion?
From NW's recent comments.
"Our long-term aim is also to help the company get into a position where it can attract the consistent funding it will need to successfully complete a Phase III clinical study and beyond. If the company is going to move into a sustainable position to attract a broader range of investors that, in turn, will give it a runway to complete its clinical trials, it needs to put these allegations to rest once and for all."
Considering these comments in conjunction with the Ondra requirement/initiative, what are everyone's thoughts concerning NW's desire or ability to continue financing NWBO? Also, curious about his Phase III comments in light of the speculation that enrollment is complete, AA is underway, and that HE reimbursement negotiations are close at hand (wouldn't revenue potential be on the near horizon?)
The first priority needs to be clearing nwbo insiders and the CEO to create the confidence level necessary for the next financing (not very far down the road). This is paramount to continue current trials uninterrupted, bring more clinics online, finish construction of facilities, and prepare for the Direct phase 2 "multiple trials in parallel", etc. If the allegations are disproven and fraudulent, eventually someone will have to answer. Clean bill of health first and quickly!
I hope it begins much sooner, but maybe that's wishful thinking.
Yes, we all invested for the science. No doubt about it. But we have to make it to the finish line intact to give the science a chance to show what it can do. That's the short term challenge.
Not panicking and still long. Just have an increased level of concern while we navigate these rough waters. Like flipper said a few days ago, "forged in the fire". The fire is hot and very uncomfortable, but necessary. One way or another there will be a resolution. I hope LP moves quickly as promised to get the investigation underway and over with.
Out of everything in the letter we decide to focus on the word punt??!! No offense to anyone here, but are we grasping so hard for anything positive that we overlook the more striking and less ambiguous parts of the letter that are very telling of NW's thoughts regarding the current situation? I'll provide my own analysis and welcome everyone to share their opinions and interpretation.
"Woodford said it was too soon to say whether the £120million bet on Northwest Biotherapeutics had gone badly." He's saying maybe, maybe not
"With some early-stage investments not everything will go well. It is too early to pass judgment on Northwest, but we have hit a bump in the road that needs to be addressed."
NW is uncertain if there is a serious problem, but he is concerned enough to demand for an ex FBI investigator's inclusion on the bod. He is actually in the same position as many of us. Invested for the potential of the science and the early clinical results, but has some concerns about the management and some of the "allegations".
And let's not forget about his prior comment regarding the timing of when he became aware of these issues and the implications this may have on future financing until full resolution is accomplished.
Look, I'm not trying to scare anyone or spread fud. I'm not someone without any interest that is "looking out for you". I'm in the same boat. Trying to figure this out. Don't know if I should sell or stay. There are strong points on either side of the argument. But we need to look at this for what it really is.
It seems highly unlikely to me that there is a coordinated effort between NW and LP. I could be wrong, but the evidence just doesn't point me in that direction. No offense Senti, I hope you won't take it personally. The reality is that our biggest backer is concerned. Should we be? I'm still long, but I am very concerned as well. In my mind the risk factor has greatly increased in recent weeks.
My biggest questions are these. What if NW finds something wrong? Will that completely erode his confidence in the current management team? Will he continue to pump more money in? Does he have the power/ownership to force any necessary changes? If not, then what happens? Does he exit? Sorry this got to be so long.
Interesting theory. Was an audit required before NW invested 180MM? Also, if your theory is true and this is a coordinated effort, why the bit about not knowing of the allegations prior to the last round of 30MM?
Flipper, quick question. In your opinion, would it be possible to use data from the information arm trial, such as OS, as supporting documentation with the application "package" for AA? I know that it would be different patient criteria than the randomized arm, but it seems if patients with a worse prognosis are experiencing an OS benefit (vs. historical norms), it is additional proof of treatment effect. Hopefully it would accompany robust PFS data (and some amount of OS data) from the 1st IA. Thoughts?
Now that NWBO has everyone's attention, can we please provide an update on the L trial? Enrollment is complete, regulatory filing is complete, everything is continuing on schedule...
I don't know, anything to remove the current uncertainty regarding the trial status..
Haha, yeah right. Have you ever been in a stock that halted trading upon the release of a PR? It doesn't matter what time of day it occures, your stop will be ineffective. But if you have just a fraction of the experience you claim, you already know this.. So why the front? So you made a few bucks from your puts... Big deal. No need for fairy tails. We really don't care about your trades or positions anyway. Everyone gets lucky now and then. Maybe your luck is about to change.
And how is your stop going to work when this opens at $20+ some morning? Just curious how you have prepared for that scenario.
Keep looking..
TC, where do you see the stock trading in the short term?
Thanks, just one question. If enrollment were complete, why wouldn't they announce it? I don't see how that could be spun in a negative fashion and it would provide a much needed sign of trial progress and completion of a major milestone. Makes no sense to keep it a secret.
Thank you. Any similar examples where a giant like NW took an active role in a company or where steps were initiated to clear the air would be much appreciated.
Could they find a more qualified individual in the areas they need to investigate and solidify? Of course we all assume they are innocent (would we remain invested if we thought otherwise?) but why hasn't anyone from NWBO refuted the allegations in the anonymous report? It has been weeks since the report was released and there isn't evidence of any attempt to address the issues or clear the air. Hence, why Woodford is now forcing their hand. Clearly he is also concerned about the lack of urgency in defending the castle.
What is there to decide? Either this is a united approach or it is something much different.
Flipper, what are your current thoughts on the continued suspension of patient screening, no announcement of completing enrollment, and no information regarding the regulatory review initiated more than 90 days ago?
It's been 2 weeks since Woodford made his request.
There are plenty of shares available and no buyers.
If someone wants shares, why aren't they buying in the 4's or 5's? This is the bargin basement and no one is shopping? Doesn't exactly jive with your opinion.
"Phase Five Research, a US firm of healthcare analysts believed to be shorting the Nasdaq-listed stock."
Why the need to try so hard to disguise their identity? Most successful short sellers are not afraid to attach their names to their work. Not this group. These cowards prefer to operate in the shadows, hide behind multiple ID's on message boards, etc. The "geniuses" behind this work are unwilling to be transparent with their credentials. And their report seems to have worked to some extent. Or at least created an opportunity for NW. All you have to do is mix in a little truth (simple stuff that anyone reviewing SEC filings was already aware of) and use that as credibility to present a hypothesis regarding the science and why it is doomed to fail. Evidently, these folks have the abilty to lift the curtain on a blind trial.
Well bravo! You won this round. But what happens if the investigation doesn't turn up any illigal or actionable items? Your report and the subsequent investigation will have significantly derisked this investment. You will have illuminated every closet and nook. Those areas of uncertainty and secrecy that likely have kept many institutions on the sidelines all of these years. You are removing all of that. If anything is found it will be cleaned up. This entire exercise is going to have a profound effect. Phase V is erasing the strongest bear argument that has ever existed with this company. After this investigation everyone will know that what remains is valid and has been thoroughly vetted. So thank you and Cheers!!
Very disappointed there isn't a PR out already. Maybe the Thanksgiving celebration has already started in the Hamptons, or maybe LP just doesn't feel this is important enough to warrant a prompt and confident response. They met on the 13th, but still aren't ready for this?
Well said. Would you agree that the best thing LP can do now is release a PR early tomorrow morning with a statement that nwbo is pleased to appoint the new director and announce to the world that she welcomes the opportunity to assist in this independent review of certain issues and allegations that have recently surfaced in order to clear the air and reassure investors.
And then on the heals of that PR, issue a second PR releasing the 1st interim results and subsequent regulatory decision :)
Flipper, what do you think about the "wonderful" Woodford news?
What do you mean?
He would have only lost about half as much if he could have covered today. But I suppose we have all had expensive lessons regarding risk at one point or another. I wish I would have made some different moves to reduce risk when nwbo was over $10 this year.
And what about hedge funds like Turing? Do you think they are concerned with small bio's?
BTW, with regard to another bio that Turing recently acquired a major stake in. Some poor sap went from what he thought was a very profitable short position to a 100k + deficit account balance in the blink of an eye. He learned a very tough lesson about shorting bio's. GL
The KBIO story makes me wonder if the end game of certain hedge funds is to bring nwbo to the brink of bankruptcy so that someone like Shkreli can snatch it up for next to nothing. Make money shorting on the way down with a big payday upon successful acquisition of the target for next to nothing. Add in the known connections of Shkreli, Cramer, and F-stein, and it starts to become quite interesting to ponder the possibilities.
Immunotherapy World 2016
January 25-27, 2016. The Grand Hyatt, Washington DC
750+ attendees, 250+ organizations from 20+ countries
Gold level sponsor - Northwest Biotherapeutics
Silver level sponsor - Cognate Bioservices
January 26th, Linda Powers will provide an industry perspective on Accelerating immuno-oncology clinical trials and maximizing success in your development.
http://www.immunotherapyforum.com/
Recap of recent events. Thank you Flipper for starting the list. I have included a few additional items. (Emphasis mine)
"A Memphis biotech firm will add up to 80 jobs after a $9.47 million expansion of its offices and clean room...
Cognate BioServices Inc.’s permit filed with the city-county Department of Construction Code Enforcement shows 32,500 square feet will be added at 4600 E. Shelby Drive...
Plans call for completing the expansion early next year." - The Commercial Appeal article, 7/17/2015 *(final permit approval on 9/24/2015)
"NW Bio confirms phase III trial of DCVax®-L for GBM brain cancer is ongoing, patients in trial continuing to be treated per protocol, including in Germany...
Over 300 patients have been recruited for the trial...
Yes, the 300 patients are actually enrolled and being treated in the trial." - NW BIO, Form 8K, 8/25/2015
"The company has confirmed that the suspension related simply to the recruitment of new patients and was a temporary measure while regulatory information was submitted, in line with clinical protocols. The trial is continuing and we see nothing untoward in this development." - Woodford Management: Mitchell Fraser-Jones, Head of Investment Communications, 9/14/2015
"No, there is no new change or delay in the Phase 3 trial. In all of our public presentations all year long, we have stated that we anticipated finishing the recruitment this fall" - NW BIO, Form 8K, 10/8/2015
"NW Bio is not aware of any fundamental reason for the substantial decline in the price of the Company's stock" - NW BIO PR, 10/19/2015
"we have explained our attraction to the long-term potential of Northwest Biotherapeutics elsewhere on this website – nothing has changed in this regard. It would be inappropriate for us to comment further at the moment." - Woodford Management: Mitchell Fraser-Jones, Head of Investment Communications, 10/19/2015
"NW Bio has reported encouraging interim clinical data from both its DCVax-L and DCVax-Direct clinical programs, both last spring and recently, with patient survival exceeding expectations...we look forward to moving these clinical programs ahead vigorously" - Linda Powers, 10/21/2015
"Detailed negotiations are now underway to build on a contract (>£2M per annum) for the CTU to serve as a manufacturing hub for the production of DCVax-L and its broader use at multiple other facilities in UK and other European Centres." - Experimental Cancer Medicine Centre, 10/28/2015
"We plan to continue adding sites to the trial, because the same institutional approvals, contract negotiations, personnel training and logistics arrangements that are needed for the trial also serve to prepare the sites for commercialization." - NW BIO, Form S-3, 11/13/2015
With regard to the S3 and shelf increase, I wonder if there is an expectation that a large number of warrants may be exercised for common shares in the near future? And who are the major warrant holders? Hmm..just thinking out loud..
I think there are a couple of clues from https://www.justgiving.com/katscure that this is indeed DCVAX L.
Patient will receive treatment for Glioblastoma with Avastin and other traditional chemotherapy treatments.
Tissue is cryogenically frozen and kept alive as it is transported to America, to create the vaccine.
Is there another DCVAX in America that would be used for Glioblastoma? Unless you mean a different version of treatment at UCLA?