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thanks Yes I have been buying 25% of my monthly salary for a long time. Now at 220k shares, hope for you, you can pick up some more :)
Of course the trial failed. Everybody knows this.
Failing to properly disclose material events regarding clinical trial data may result in more than harm to company’s reputation. It could lead to an investigation by the SEC and/or DOJ if the agencies believe that the company has intentionally deceived investors. The FDA may assist these inquiries, and in fact, the FDA and SEC now have a specified mechanism in place that facilitates FDA reporting to the SEC if they come to believe that a company may have made a false or misleading statement to the investors. SEC and DOJ investigations pose a much graver risk than ordinary commercial litigation, as consequences may include substantial fines for the company and its executives, bars on serving as an officer at a publicly traded company for a period of time, and, in extreme cases, criminal prosecution including potential jail time.
I think we should all prepare to wait as far into Q1 could be Jan could be March 2022 then the SP will move to >5$ finally
meanwhile I bought another 10K shares today at 81
yup lol yes thats me
so are you saying the trial failed? are you?
so you have no problem asserting NWBO management and its scientific board of directors are swindlers, crooks for not disclosing a failed trial and will be investigated by DOJ and or SEC?
https://westwicke.com/2019/11/keys-to-successful-disclosure-of-clinical-trial-data-and-milestones/
The bad news: Failing to properly disclose material events regarding clinical trial data may result in more than harm to company’s reputation. It could lead to an investigation by the SEC and/or DOJ if the agencies believe that the company has intentionally deceived investors. The FDA may assist these inquiries, and in fact, the FDA and SEC now have a specified mechanism in place that facilitates FDA reporting to the SEC if they come to believe that a company may have made a false or misleading statement to the investors. SEC and DOJ investigations pose a much graver risk than ordinary commercial litigation, as consequences may include substantial fines for the company and its executives, bars on serving as an officer at a publicly traded company for a period of time, and, in extreme cases, criminal prosecution including potential jail time.
if the data would show DCVAX L is inefficient and just does not work then t would be incredible unethical for NWBO/Advent to continue to offer the treatment. Dr Liau would of course also stop her support.
The approval for compassionate treatment would also be revoked.
But legally they are in that case allowed to continue to offer the treatment as the are many dodgy treatment of all sorts of lethal illness offered without FDA approval as log as its safe which has been proven it is.
We won’t know what Advent gets paid, but it will be less than Cognate was paid because we own the site they’ll manufacture DCVax-L in.
we should also realize that there is a big difference between actual revenue and potential revenue. NWBO at present falls in the latter category. I expect this to change in 2022 for NWBO but until then the comparisons between Bios with a MC of of 10/15/20 x their actual revenue can not yet be made. Still NWBOs MC after the certification is heavily undervalued.
Ooh dear. I pray and wish you will recover soon and wish for you to have the strenght to overcome this. God speed Irdpdx77 I hope that DCVAX can help you in you treatment
and my wife is excited too as we all are waiting for topline data + the publication
I added 20,000 shares this morning and will add more depending on price movements (my wife is getting a bit nervous so I need to time future purchases to continued good news).
the Duffy man again…LOL .. he ran away screaming after seeing how LP works ..
But the case is being made that publication can be delayed at the request of the authors/company. My sense of real world dynamics, that’s probably true if you have enough street cred.
100% agree
Stocks however react to revenue mostly less to assets and IP inflation by a listed company
now that at least compassionate use could bring in well over 50 million per year in 2022 it would be just to see a 2 billion MC.
This stock is way way undervalued.,
I think they are trying to convey its their manufacturing partner in the UK. To suggest its their subsidiary would be too much of a blunt lie
I dont understand what you are getting at you mean to hint/say that NWBO is referring to Advent specifically as their GMP for the UK or do you mean to say that it is THEIR entity as in subsidiary (which would be a falsehooid its Toucan’s)?
other than that your post was the most redicolous remark ever made on this board shorty ;) ;) hahaha lol
The MHRA license approval enables the manufacturing of DCVax-L products to get under way at the Sawston facility in addition to continuing at the smaller GMP facility in London. The license also permits the import and GMP manufacture of other cell therapy products under the UK's supply of unlicensed medicinal products ('Specials') regime and for clinical trials under the Investigational Medicinal Products (IMP) Programme.
most people are confusing missed timelines with failed trials. Funny thing is that in general its the other way around failed trial often means successful trials... I mean how much time does it take to rap up a failed trial when concluded as such? It take much, much more time to communicate and commercialize a successful trial.
The certification is not ONLY to produce DCVAX products but to produce Human Investigational Medicinal Products Under which DCVax falls, correct.
What I dont understand is some asserting that Advent would not be enough to get FDA approval but only EMA/Uk. The production facilty will be good enough for the FDA under certain circumstances.
Statements made by life science and medical device companies are thoroughly scrutinized by the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ), since investors rely heavily on these disclosures when making their investment decisions. Mistakes made while disclosing events of the clinical trial lifecycle can cause a serious crisis for your company: analysts may downgrade your stock, investors may dispose of your shares, and your stock price may plummet. Such errors will also harm management’s credibility and reputation, your company’s most valuable attributes.
The bad news: Failing to properly disclose material events regarding clinical trial data may result in more than harm to company’s reputation. It could lead to an investigation by the SEC and/or DOJ if the agencies believe that the company has intentionally deceived investors. The FDA may assist these inquiries, and in fact, the FDA and SEC now have a specified mechanism in place that facilitates FDA reporting to the SEC if they come to believe that a company may have made a false or misleading statement to the investors. SEC and DOJ investigations pose a much graver risk than ordinary commercial litigation, as consequences may include substantial fines for the company and its executives, bars on serving as an officer at a publicly traded company for a period of time, and, in extreme cases, criminal prosecution including potential jail time.
https://westwicke.com/2019/11/keys-to-successful-disclosure-of-clinical-trial-data-and-milestones/
Public companies scream it out loud when they have a winner. Not pass out tote nags.
No it really does not work like that like as women cant be half pregnant And Im being culturally inappropriate here so let me correct myself by saying men cant be half pregnant either (nor can they full stop lol)
Seriously NWBO knows by now if their chance of approval is very realistic aka the trial failed or not, if not then as such they should have reported this within 4 business days full stop no buts and ifs. THUS the trials HAS succeeded aka management+ the scientific board is convinced L will be approved UNLESS the scientific board and management are securities swindlers as what you probably think they are
However, the one thing that these type of articles point out is the weakness in LP’s strategy to indefinitely withhold TLD because they need a Journal Article to fend off attacks against the results (and the company). Well, the longer they wait to release TLD, the more vulnerable the company becomes to negative sentiments, and likely from much more credible sources. The very thing that LP is trying to ostensibly prevent is exactly the kind of thing she’s creating.
lol yup a real pro
Northwest Biotherapeutics: No TLD Yet
Dec. 19, 2021 12:12 PM ETNorthwest Biotherapeutics, Inc. (NWBO)14 Comments
Summary
NWBO still has not announced toppling data, or TLD.
This situation has been ongoing for more than a year after data lock.
I will continue to hold, but will not add to my small position.
Today is exactly one year since I wrote about Northwest Biotherapeutics' (OTCQB:NWBO) impending unblinding. Given what we saw from interim data in 2018, and the pedigree of DCVax-L, and the experts vouching for the product and so on, and not to forget the 18-year long trial, nearly unheard of in biopharma - given all of these, the unblinding would have been a momentous affair. However, after more than 14 months of data lock, we still do not have unblinded data from the trial.
The thesis is simple enough. Glioblastoma patients hardly survive a few months after the disease is detected. 12-18 months is the average survival, only 25% live beyond one year, only 5% beyond 5 years. Patients from the Phase 3 trial of DCVax-L have continued living way, way longer, with median survival of more than three times the standard GBM patients. However, because the trial is still blinded, we still do not know if, by some miracle, placebo patients have survived this long. If only DCVax-L patients have shown such outstanding survival rates - which is the likelier explanation for the data - then these results are truly outstanding. However, the company's unbelievable delay in unblinding the data, and their studied silence, have wrecked the stock.
In their latest 10-Q, as before, the company has continued to blame Covid-19 for the inordinate delay:
As previously reported, coronavirus-related difficulties have impacted most aspects of the database lock and the process of analyzing the Phase III trial results, especially with the successive waves of COVID-19 cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial sites have not allowed personnel from the contract research organization managing the trial, or other service providers, to visit the sites for trial matters such as data monitoring and collection activities. Clinical trial site personnel have been unavailable due to being reassigned for COVID-19, and the limited site personnel have had to work under restrictions. Committee processes and regulatory processes have been similarly focused on COVID-19 matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain analyses, and the firms conducting the analyses have had only limited operations. Even logistical matters such as the shipping of materials have been subjected to substantial restrictions and delays.
Northwest Bio is not the only company running a trial during the pandemic. Other companies have successfully completed trials and had their drugs approved. Even the FDA, which from all indications has suffered the pandemic poorly, has continued holding PDUFAs and approving drugs. Therefore, Northwest Bio's long Covid-19 disclaimer does seem a little too defensive. The company is nearing the brink of a financial precipice, and doubt remains about their being a going concern for too long:
Because of recurring operating losses and operating cash flow deficits, there is substantial doubt about the Company's ability to continue as a going concern within one year from the date of this filing.
Northwest Bio managed to get $15mn financing in late November with what appears to be considerably lenient terms given the situation:
Northwest Bio…announced the closing of a $15 million financing on November 22, 2021, which brought the Company's cash reserves above $20 million.
…The financing is in the form of a 22-month loan which requires no payments for 8 months, and then provides for a subsequent 14-month amortization period. The loan has a provision for prepayment, an annualized interest rate of 8% and OID of 10%. Upon announcement of the top line data ("TLD") from the Company's Phase III clinical trial of DCVax®-L for Glioblastoma brain cancer, the lender will have a then-springing right to exchange the outstanding balance of the loan for common shares priced at the price of the first private placement transaction following TLD less a 12% discount, and to purchase another 50% of that number of shares at the same price. This then-springing right expires 14 days after that post-TLD private placement.
Clearly, the lender is hoping for superb top-line data from the trial, when they can make a windfall by buying shares at a discount.
This lender has more money and more optimism than a lot of us NWBO shareholders. I took a position in NWBO three months ago, and my holdings, although small, have fallen in value by nearly 50%. I do not plan to increase my position, however I am not going to sell out either. They just announced that their UK facility has been granted a license to work with human tissues for medical products by the UK Human Tissue Authority (HTA). They also announced that the UK Medicines and Health Products Regulatory Authority ("MHRA") has inspected the facility as part of a process of granting license to manufacture products like DCVax-L. Northwest Bio will continue to make such minor announcements, and shareholders such as us will continue to hope, against all logic, that this company will one day deliver what we have been waiting for nearly two decades - TLD.
This article was written by
Avisol Capital Partners
who needs enemies such as AF if you have friends like NWBO management lol
I think NWBO once again underestimated how long the journal publication would take and then also all kinds of events happend since datalock. After they cannged their minds to publish an scientific article in coordination with TLD they could not chance their minds back again. And thus here we are waiting for the publication in a scientific journal which took months longer than the 14 months medium publication after datalock according to DI.
yes as poorman has been saying here for a long time NWBO will be acquired I agree. But remember this is NWBO and in the world of NWBO everything goes much much slower then on planet earth.
If Einstein would still be alive, he would be all over this incredible rare physics phenomenon called NWBO and probably had to rewrite his idea on time and mass.
After publication it will take many many, many months before the acquisition of Northwest will be announced. We will need formal approval by all 4 RA’s, we need uplisting etc months months
poorman IMO if the results were gray or grey than a scientific outlet would not be of much interest to an scientific outlet and NWBO would be deprived of its publication. In that case NWBO had to disclose by now that a scientific publication is not feasible or correct their still standing statement that they are working on a scientific publication. just MO
wrong on 3 accounts first "Germany" did not say anything. The EMA, which is not Germany, however bought in NWBO new endpoints. The UK follows the EMA
I don’t think any of the latest wait has anything to do with the possibility of questionable results, I instead believe it has to do with reimbursement and manufacturing capacity considerations.
it sounds like you are really disappointed?
At some point they will have to publish the article or they had to disclose they will not able to. And the not being able to publish the article deadline has come to pass long agoe thus we will see the publication given the few months delay after 14 mOS soon enough.
The reason they are refusing to release the data is because it is bad
Jan or Feb is what I think
The company has repeatedly stated they would only want to disclose TLD in coordinated with a scientific publication. DI has said publication has a usual timeframe of mOS 14 months after data lock but is now confronted with a few months delay because of Covid. So Oct 5 2020 + 14 months is Dec 5 2021 + 2 months delay is…. Exactly
If you look at the history of DCVAX L trial you will understand NWBO has a LOT of positive explaining todo pseudo progression, endpoint change, GBM definition change by WHO and thus its incredible understandable they want to coordinate TLD with a publication. IMO if they had disclosed TLD in Nov 2020 then A. Medical KOLs (and not shorts or AF) would have asked many understandable questions left unanswered and B. They had to recalculate and again disclose TLD after WHO redefined GBM
The SP decline is warrant holders that have haven exercised and selling because of profit taken after nothing had happened after SNO AND NWBO letting these warrant holders exercise. Remember NWBO did manage warrant holders NOT to exercise for almost 1 year but that cat has been left out of the out of the bag now by NWBO. Also the risc off market and biotech down does not help either. All IMO
we are in the same team Cherry I understand the tremendous potential of DCVAX platform. NWBO is therefore tremendously undervalued IMO, your opinion and many longs opinions.
Most listed companies are being valued by its future cash flow/market potential, reality however is that mr market has put NWBO for now on a first see then believe basis and does not recognize its future potential until proven otherwise. So buy opportunity!!
its a true statement and for the following reason.
It would be of a tremendous utmost extreme stupidity to lock the database without discussing with the FDA their stands on endpoints change. If the FDA advises to do some parts of the amended SAP differently than then that is very difficult to adhere to after the database has been locked already.
Second. Despite as what others (ex) may tell you. Its no big deal to change endpoints / adjust SAP with the FDA prior to datalock. The only rule the FDA will impose is the employees/staff involved in the SAP adjustment must be objective.
Go ahead and Google FDA policy towards endpoint change/ SAP adjustment prior to data lock. You will notice it is as I described.
Third. Its well known that any biotech with any meaningful clinical trial are in regular discourse with the FDA especially when it comes to SAP adjustment. If the FDA would have advised against the change IMO that is a material event ans must be disclosed
. . . so you think this is just more warrants being exercised driving the price lower?
we will need a special stock holders meeting to vote for a split. In Delaware 2/3 of votes are needed if Im correct. This is NOT going to happen without TLD