NWBO: Once In A Decade Best Stock Investment -- Regulatory Approvals Coming! [Dec10, 2022 在第一页加了中文简述]

Henri 说:
Someone said GNS went from 0.54 to 3.24 in 2 days just by issuing a special dividend to trap those who were naked shorting the company. If this is true, we should do the same.
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Henri, GNS and NWBO are two totally different companies. One is established in educating entrepreneurs with 60% growth rate while the other is still a development stage biotech company aiming to treat all solid cancers though its treatment for first indication (GBM) is now at the stage of awaiting regulatory approvals.

In the scale of financial potentials, GNS is tiny (billion if fully materialized) but relatively mature while NWBO is gigantic (tens if not hundred of billions if fully materialized) but still awaits the nod from regulatory agencies for approving its first cancer treatment (DCVax-L) indication with completed clinical trials.

GNS is trading in NYSE while NWBO after de-listed from NASDAQ years ago still trades in OTC where institution investors are prohibited to participating, which means GNS's short-squeeze probably resulted from retails investors but mainly institutions who long the stock after concrete steps taken by the company, while NWBO, even taking some concrete actions today such as issuing some special dividend, may initially see a short-squeeze but the squeeze may be hard to sustain afterwards lacking institutional participants. In that scenario, it's good for traders but not good for long-term investors and the ultimate corporate values.

There are other numerous reasons stacked against the timing is now for NWBO as well. But bearing in mind and rest assured, NWBO are basically run by two high-caliber very successful persons, one is a lawyer and former partner of a very famous Washington DC law firm, who was once Trump's lawyer for some of his Washington DC real-estates while the other is a Harvard law graduate, a major US governmental participant and architecht for NFTA.

They would know when is right time to upper the ante. In a matter of fact, the legal battle has been going smoothly ever since NWBO launched a lawsuit against sever market makers in early last December. Since then, the defendants has resorted to delay and deny tactics as expected and responded with a motion to dismiss, and the firm representing NWBO has countered with persuasive letter (see below within the tweet). I believe we will reap a windfall from this suit besides a much anticipated short squeeze as a result from it.

 
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Patience, perseverance, and wait always have new meaning with regards to NWBO. Just killing time in this regard:
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MIA approval could be days apart. Not what I really care, no intentional to sell in any small pops (dimes).

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During 13-31 Jan short interest (the part of legal short) drops by 2.6 million shares, or the shorts had bought (covered) 2.6 million shares, but share price had actually dropped from $0.73 to $0.71. Of course the culprit is manipulation. Anyhow, as expected news of MIA is overdue, the spring has been pressed hard. It's time to buy.

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One more way to show efficacy of DCVax-L (Murcidencel) in treating n and rGBM patients.

Assessment of Treatment Response to Dendritic Cell Vaccine in Patients with Glioblastoma using a Multiparametric MRI-Based Prediction Model

Purpose Autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) is a promising treatment modality for glioblastomas. The purpose of this study was to investigate the potential utility of multiparametric MRI-based prediction model in evaluating treatment response in glioblastom...
www.researchsquare.com www.researchsquare.com
Research Article

Assessment of Treatment Response to Dendritic Cell Vaccine in Patients with Glioblastoma using a Multiparametric MRI-Based Prediction Model​



Assessment of Treatment Response to Dendritic Cell Vaccine in Patients with Glioblastoma using a Multiparametric MRI-Based Prediction Model

Purpose Autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) is a promising treatment modality for glioblastomas. The purpose of this study was to investigate the potential utility of multiparametric MRI-based prediction model in evaluating treatment response in glioblastom...
doi.org doi.org
This work is licensed under a CC BY 4.0 License

Purpose​


Autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) is a promising treatment modality for glioblastomas. The purpose of this study was to investigate the potential utility of multiparametric MRI-based prediction model in evaluating treatment response in glioblastoma patients treated with DCVax-L.

Methods​


Seventeen glioblastoma patients treated with standard-of-care therapy + DCVax-L were included. When tumor progression was suspected and repeat surgery was being contemplated, we sought to ascertain the number of cases correctly classified as true progression (TP) + mixed response or pseudoprogression (PsP) from multiparametric MRI-based prediction model using histopathology/mRANO criteria as ground truth. Multiparametric MRI model consisted of predictive probabilities (PP) of tumor progression computed from diffusion and perfusion MRI-derived parameters. A comparison of overall survival (OS) was performed between patients treated with standard-of-care therapy + DCVax-L and standard-of-care therapy alone (external controls). Additionally, Kaplan-Meier analyses were performed to compare OS between two groups of patients using PsP, Ki-67, and MGMT methylation status as stratification variables.

Results​


Multiparametric MRI model correctly predicted TP + mixed response in 72.7% of cases (8/11) and PsP in 83.3% (5/6) with an overall concordance rate of 76.5% with final diagnosis as determined by histopathology/mRANO criteria. There was a significant concordant correlation coefficient between PP values and histopathology/mRANO criteria (r = 0.54; p = 0.026). DCVax-L-treated patients had significantly prolonged OS than those treated with standard-of-care therapy (22.38 ± 12.8 vs. 13.8 ± 9.5months, p = 0.040). Additionally, glioblastomas with PsP, MGMT methylation status, and Ki-67 values below median had longer OS than their counterparts.

Conclusion​


Multiparametric MRI-based prediction model can assess treatment response to DCVax-L in patients with glioblastoma.
 
More and more people will ultimately realize today's NWBO to biotech is yesterday's Apple to high-tech. Both are powerful platform technologies, one proven while the other is on its way to be proven.

Toward that glorious goal, first regulatory approval will be the most critical step.
 
The ihub post below is removed in that short infested board:


Removed Message

Judged with the cropping up of those familiar, useless, repetitive, nonsensical if not outright false commentaries in this board, almost to a level of dominating in volumes and counts, well it seems those fellas are either emptiness of shares or minus of shares. So I would not take them any seriously.

Or as usual some of those fellas may mostly just try to make a living by swing trading, but they may mostly actually pay to live judged by the manipulated nature of price by the now accused 8 market makers, and their own unethical, dishonest, self-harming commentaries.

We all know our "mom and pup" are old. They may be slow but careful, experienced, certainly have achieved something substantial in a way in that only true longs can understand, because we don't count how many days the price was down or up, and in which specific days. We aim at major milestones in a manner in which they are not solely determined by company's prs or any general regulatory guidance, but in effect they will come when it come.

Yes dilution is a problem, and in effect it's the only problem if I must come up with a problem. But since we have been holding way too many shares, that kind of dilution is just peanut.

With the overwhelming evidence (data) from the trial (JAMA Oncology Paper), and numerous strong supporting data such as "Assessment of Treatment Response to Dendritic Cell Vaccine in Patients with Glioblastoma using a Multiparametric MRI-Based Prediction Model?," and most importantly the pristine safety profile of the vaccine, we know DCVax-L (Murcidencel) will be approved and commercially used in not distance future! [thank you Linda for those words re MIA despite not really understand what that means). It doesn't matter when MIA will be granted, MAA will be submitted, or when MA will be granted... whether it is in "not distant future" but it will come. yes I pray it comes sooner, much sooner than otherwise has been expected.

In conclusion, we know we will be there, the same goes with FDA, and the regulatory bodies in the rest of the world.

The dilution should be minimized as much as possible, and our "mom and pop" shall go a bit more fast on our behalf.

Holy blessing is a wonderful thing. Magic does happen. We certainly have unknowns, blessing and surprises. I am a believer.
 
If a market maker is corrupted, well SEC would say it's just a weed; how about most market makers are corrupted. NWBO's case against 8 market makers is open for anyone to have a look. Plain and desperate market makers who shall be punished according to the law if SEC is not just watching the porn. In my calculation, the fine should amount to a billion.

Citadel again filed for extension:


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NWBO lawyers response:

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Judge Gorenstein extension only granted until 3/20/23
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最后编辑:
10-k was out yesterday. This fella summarizes it succinctly:


r/NWBO
•Posted by
u/BIO9999
5 hours ago

Quick takeaway messages from the $NWBO 10-Q
Due diligence
NWBO's 10-K is out. I've never read an exciting 10-K before for any company--they're designed to be full of caveats and concerns and worries and stuff. Anyway, these are the takeaway messages I took away. Read it yourself here: Inline XBRL Viewer

The MHRA is getting ready to sign off on MIA.

“The application package was submitted at the end of June, and reviewed by the regulatory authorities over the following months. An initial onsite inspection by regulatory authorities took place in October for the commercial license application, and also served as the annual review/renewal inspection for the prior licenses for compassionate use and clinical trial manufacturing. Further submissions and interactions with the regulator took place between October and February, and a follow-up inspection took place in early February 2023. The Company is now awaiting any further requirements or communications from regulators.“

Contract discussions in the US are ongoing.

“In the US, the Company entered into contract discussions for resumption of manufacturing capacity there.”

The company is going to sublease Sawston for other cell manufacturing, thus producing income and making Sawston more valuable.

“In light of this, and in light of our obligation in connection with the buildout loan from the Cambridge development authority to make the Sawston facility benefit the regional business ecosystem and not just us, as previously reported we entered into a sublease on December 31, 2021 for a small portion of the space to our contract manufacturer, Advent BioServices. For further details, please see Note 10 below. It is anticipated that, as and when feasible, the subleased space may enable some production of third party cell therapy products. Such production of other products will fulfill the loan-related commitment to the Cambridge authority, will help support the capital-intensive Sawston facility costs and, in light of the growing demand for cell therapy manufacturing capacity, could substantially increase the asset value of the Sawston facility.”

Flaskworks will make it simpler and cheaper to scale up.

“Flaskworks system will enable substantial scale-up of production volumes of DCVax products and potentially substantial reduction of production costs (including potential reduction of indirect costs related to capital-intensive facility costs). We anticipate that implementation of the Flaskworks system will enable certain phases of the Sawston buildout to be simplified and streamlined.”

It has a ton of patents including 13 new patent families from Flaskworks.

It has 7 year US and 10 year Europe orphan drug exclusivity on DCVax-L--which will start when sales start.

“In addition to our patent portfolio, we have obtained Orphan Drug designation for our lead product, DCVax-L for glioma brain cancers. Such designation brings with it a variety of benefits, including potential market exclusivity for seven years in the US and ten years in Europe if our product is the first of its type to reach the market. This market exclusivity applies regardless of patents (i.e., even if the company that developed it has no patent coverage on the product). In addition, the time period for such market exclusivity does not begin to run until product sales begin. In contrast, the time period of a patent begins when the patent is filed and runs down during the years while the product is going through development and clinical trials.”

They will next do a Phase II trial of DCVax-Direct.

“We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit.”

Specials income (as estimated from the “Research and Other” section) is accelerating since the JAMA Oncology article. Q1 2022 was 403k, Q2 was 477k, Q3 was 206k and Q4 was 597k
Quick takeaway messages from the $NWBO 10-Q
 
Wish you will be lucky soon. ACER has dropped to around $2.0 and wait for an entry price.
 
Thanks for your wish, same to you. I have long realized this stock will not have fundamental trend change unless regulatory approvals. It's particularly true now that NWBO has launched lawsuit against the 8 biggest market makers who make the market for nwbo stock (suggesting it's in their DNA now not to help the stock). Although I am quite sure we will win the suit and get significant monetary compensation, maybe up to a billion if our lawyer is as tough as our will to see this company succeed. And it's no doubt we will succeed, with the caveat that this process may be a long journey (months, or a year).

IMO, nwbo has a floor around $0.6s, which has significantly higher potential (10 bagger as approvals). This stock is a hold for long-term gain.

[I won't buy any acer at the time being since I have continually added nwbo. Good luck there for you]
 
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