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

if DCVax-L were to applied for in the UK and Canada through their Fast Track process. That guarantees 150 day answer?

So hopefully by end of January next year?
 
In the matter of NWBio, I have long learnt to not have any questions on their timelines. Nonetheless, the company this time seems to be really ready to submit a marketing application, probably to UK first. The approval could then come within months or a year after the submission. For instance, if the company submit it by the end of this month, then the time of approval may be around, yes, early next year.

However, if the long delay we have suffered so far is due to more than normal close consultations with regulatory agencies regarding marketing applications, particularly the requirements / contents for approval so that the company has already taken so much more time than usual so that it can get the application pakage right, avoiding potential back and forth with regulatory agencies, then the approval may come much earlier, particularly if the regulatory agencies have already reviewed and given feedback on some of the modules within the applications.

One other thing to look forward this time around as it is mentioned in the 2nd Q is the combination trials, which may preceded with some kinds of partnership deals.
 
For those of you who want to get rich quick (no pun intended), now this is the time. At about $0.48 a piece for around $600 million market cap NWBO will be your most rewarding investment ever depending on how much money you are willing to put into work.

It's almost a guarantee DCVax-L will be approved for GBM. That alone will warrant multiple beggar if not more. So why the price is so low now: nobody cares even not from the company, retails are tired and running out of cash to buy, no publicity no new investors, its late summer, general market for biotech not favor, .... of course I shall not forget to mention the 7 accused MMs, and evil shorts.

In the near future, one can expect the company will submit market application (my estimate definitely before the end of Sep, and probably sooner), then approval thereafter within months.

So who would be beneficial from the low price today: the management (CEO Linda, VP Les Goldman and the gang) who would be awarded shares and warrants at low price when milestones are hit; a few financiers who will also get cheap shares by putting money into the company now or with an arrangement when milestones are hit, a few retails who have adequate funds to continually buy at this price, and of course the evil shorts who can cover their buts relatively easily and cheaply in the end. Once again unfortunately but realistically, the vast majority of retail investors who have been recognized by CEO Linda as the backbone support of this company are loosing. Ironic? NO!

Lastly, remember, your money your responsibility not mine unless you are willing to share your profit with me. GL
 
最后编辑:
Nothing really can be added except waiting, so some rhetoric:


Dan88
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12:24 PM

Post #622,409

Have Linda and Les done a good job? I would say yes they actually have done a super good job albeit alone almost without the help of any capable deputies. DI and the like are just window dressing. They just serve as a buffer or something non essential.

But because of the age of Linda and Les -- around 70 in average, they can do only that so it's no surprise to see delay, delay and delay, of course a significant part of that is due to the complex nature of seeking approvals of DCVax-L by multiple RAs from a trial which is unprecedented in many ways. Nonetheless it will be definitely approved by the multiple RAs due to its results are "both statistically significant and clinically meaningful" -- conclusion from the high-impact JAMA Oncology landmark paper.

During the long delayed process, the vast majority of retail investors who have been repeatedly recognized as backbone of the support to the company by Linda have suffered emotionally and monetarily due to in a significant part, heavy dilution.

The management, mainly Linda and Les can and should show that we, the vast numbers of retail investors and the management are truly in the same boat; we shall suffer, endure, flourish and prosper together. The management can at least do the following:

1) Buy in open market, if having not yet scheduled, do now;

2) Rearrange the pay package. Cut substantially the future milestone payments of both shares and warrants; Compared to injecting new valor and confidence to the investment community by doing so, I don't see any difference of rewarding themselves with 30 millions or 15 millions of warrants (just example, not the real numbers); and

3) Throw off the shackles of the myth that FDA is a totally corrupted monster which has been better not poked or "offended" in any way so that NWBio shall continually operate in a stealthy mode behind the scene. Well the publication of the JAMA Oncology paper has changed that, or everything in effect. Nothing should we fear for now, and Linda and the gang shall embark on a new journey so that we won't be so passive anymore and instead we should take a more proactive role, fanning out people to promote the company as much as possible. Truth flourishes in light, not darkness!

When we remember the conclusion from the high impact JAMA Oncology paper re P3 DCVax-L trial for GBM: the results are "both statistically significant and clinically meaningful," nothing and nobody shall we fear! We should be in the teens when clouds are clear and dusts are settled. In the meanwhile, get dry powder ready to chase the shares until the 7 accused MMs and their complicit short can no longer manipulate the market.
 
Below is an opinion piece truthfully and beautifully written by our young lawyer and fellow investor Hoffmann6383 on reddit:




The American System - Profits Over Life; $NWBO’s Battle to Bring a Cancer Vaccine to Market

[OPINION]
By: Hoffmann6383
There is a small and obscure biotechnology company attempting to bring a personalized vaccine to long suffering Glioblastoma (“GBM”) patients. GBM is the most aggressive and deadly form of brain cancer. This company, Northwest Biotherapeutics, Inc (“NWBO”), completed a phase III trial using a personalized autologous tumor lysate-loaded dendritic cell vaccine, called DCVax-L, that showed a clinically meaningful and statistically significant improvement in survival of GBM patients[1] and are now attempting to bring this treatment to market. On the other side, market makers and hedge funds (the “Wolf Pack”) are doing everything in their power to keep this vaccine from getting to the market in an effort to protect their own pocketbook.
NWBO started their DCVax-L Phase III trial in 2006 (the “Trial”).[2] The Trial took about 2 decades to complete.[3] It cost hundreds of millions of dollars.[4] The complexity of the blood-brain barrier in addition to the cost and time required to conduct a Phase 3 study has made progress in the treatment of GBM a rare occurrence. Newly diagnosed glioblastoma (“nGBM”) patients haven’t seen an improvement in standard of care (SOC) since 2005.[5] Recurrent glioblastoma (“rGBM”) patients have no SOC.[6] A diagnosis of GBM is near certain death.[7]
There are 14,490 Americans that are expected to receive a GBM diagnosis in 2023 and more than 10,000 that will die.[8] None of this mattered to the Wolf Pack. The Wolf Pack made a bet against NWBO and they are doing their best to protect that bet, i.e. naked, unreported and/or underreported short positions. To this end, the Wolf Pack has extensively and illegally manipulated NWBO’s share price and they have engaged in an enormous distortion campaign on social media despite real life consequences to NWBO, NWBO shareholders and most importantly, cancer patients. In this article, I’ll (1) introduce you to NWBO, (2) walk you through the lawsuit alleging illegal share price manipulation, (3) give a first-hand perspective of the social media distortion campaign and finally, (4) give some closing thoughts.
Who is Northwest Biotherapeutics, Inc.?
Northwest Biotherapeutics, Inc. is a clinical stage biotechnology company focused on the development of personalized cancer vaccines to treat a broad range of solid tumor cancers.[9] NWBO’s lead treatment is DCVax-L, and the company has completed a Phase III nonrandomized controlled trial of 331 patients with GBM, a deadly brain cancer.[10] Five-year survival for nGBM is less than 5%.[11] The SOC for nGBM consists of surgical resection of the tumor, radiation therapy, and concomitant and adjuvant chemotherapy with temozolomide.[12] Nearly 100% of the tumors recur. There is no SOC for rGBM.[13] Since 2005 there have been hundreds of clinical trials in nGBM and rGBM. Prior to the results being shown for the DCVax-L trial, survival benefit has only been shown in one phase 3 trial in nGBM and no phase 3 trials in rGBM have shown a survival benefit.[14] That is until NWBO’s autologous tumor lysate-loaded dendr
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itic cell vaccine (DCVax-L) demonstrated a survival benefit in nGBM and rGBM patients.[15]
A JAMA Oncology paper published on November 17, 2022 showed that adding DCVax-L to SOC showed a clinically meaningful and statistically significant improvement in mOS with both nGBM and rGBM when compared with matched, contemporaneous external controls.[16] On March 20, 2023 NWBO announced they received one of the first Medicines and Healthcare products Regulatory Agency (“MHRA”) licenses in the UK for commercial manufacturing of cell therapy products that allows for global delivery of their cell therapy products.[17] In an interview published July 14, 2023, Les Goldman, Senior Vice President of NWBO, stated that the company will be applying for approval in 4 places with the MHRA in the United Kingdom being the first.[18] On August 9th NWBO filed their 10-Q for the second quarter of 2023 and stated that the company “is now in the final stages of preparing an application for regulatory approval of DCVax-L.”[19] NWBO went on to state that they are involved in “active discussions in regard to certain combination treatment regimens, and is planning for certain strategic trials with such combination treatments.”[20] DCVax-L is currently being used in two ongoing combination trials. One UCLA trial involves DCVax-L combined with poly-ICLC.[21] This is for nGBM and rGBM and unpublished data is showing approximately 50% overall survival at 100 months.[22] Another trial involves DCVax-L, poly-ICLC and Keytruda.[23] This trial is for rGBM and unpublished data is showing approximately 60-65% survival at 800 days (Figure 1).[24]

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On June 3, 2023 NWBO presented at the Industry Expert Theater at ASCO. You can see this presentation and much more information on NWBO here: Home - Northwest Biotherapeutics

Illegal Share Price Manipulation – The Spoofing Lawsuit

Spoofing is a form of disruptive algorithmic trading activity to manipulate the markets.[25] Spoofers place bids or offers on stocks with the intent to cancel before the orders are filled.[26] Spoofing may cause prices to change because the market interprets the one-sided pressure in the limit order book as a shift in the balance of the number of investors who wish to purchase or sell the asset, which causes prices to increase (more buyers than sellers) or prices to decline (more sellers than buyers).[27]

On April 10, 2023, NWBO filed an Amended Complaint in the U.S. District Court for the Southern District of New York alleging that market makers Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Susquehanna International Group LLP, Virtu Americas LLC (collectively “Defendants”) deliberately engaged in repeated manipulative spoofing of NWBO’s stock from December 5, 2017 – August 1, 2022 (Figure 2).[28] NWBO states that Defendants engaged in 2,849 spoofing incidents occurring on 395 of 1,171 trading days, or nearly 34% of the trading days, in the relevant period.[29] NWBO sold over 283 million shares at manipulated prices, 49 million of which were sold at the closing price on dates where spoofing episodes occurred.[30] NWBO claims that the market manipulation directly impacted the price of NWBO’s shares sold into the market, causing NWBO significant losses as the stock was sold at artificially depressed prices.[31]

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May 10th, 2022 was the single most egregious day of illegal share price manipulation on record according to the Complaint.[32] There were a total of 100 spoofing episodes between Defendants totaling 2,883,387 shares of fictitious baiting orders (Figure 3).[33] On that day the market learned NWBO met both its primary and secondary endpoints with statistical significance, displayed an excellent safety profile and showed meaningful increases in long-term tails of the survival curves for both nGBM and rGBM.[34] Despite the excellent trial results, the share price declined from $1.73 to $0.3862, a 52 week low.[35] This was a 78% decline of the share price on a day with nothing but positive news related to NWBO.[36]

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A large portion of the spoofing incidents on May 10, 2022 occurred prior to the DCVax-L data being presented publicly, for the first time, at 11:10 EST.[37] For example, 13 of 29 spoofing incidents by Citadel Securities, LLC (“Citadel”) occurred prior to the data being presented publicly.[38] Citadel executed 24 of their 29 spoofing incidents on May 10th prior to the presentation being completed. Essentially, Citadel wanted the market to think the trial results were a failure before the market even digested said results. It wasn’t just Citadel that wanted to portray the DCVax-L trial as a failure. It was all of the Defendants. We also had the head of a hedge fund live tweeting that the trial had failed.[39] There was a reporter claiming the trial had failed.[40] This reporter, Adam Feuerstein, is cited in Defendants’ Joint Memorandum of Law in Support of Motion to Dismiss Amended Complaint for the proposition that NWBO suffered a crisis.[41] The Defendants claim it was a “crisis” when the positive DCVax-L Phase III data was presented.[42] When Citizens for Responsibility and Ethics in Washington executive director, Melanie Sloan, asked the SEC to investigate NWBO’s stock for market manipulation she paid particular attention to Adam Feuerstein, whose relentless blog posts have not only been filled with exaggeration, mischaracterization and half-truths, but curiously have also coincided with spikes in short trading.[43]

The Defendants described their actions as “bedrock market-making activity” and if they are unable to continue with this activity it could potentially upend “the entire U.S. equity market system”.[44] Essentially, spoofing is part of Defendants’ business model and if anyone tells them to stop, they are going to bring down the entire market.

Despite Defendants’ claims, spoofing is illegal, period. Spoofing is not a “bedrock market-making activity”. This is an activity that lands you in jail.[45]

Spoofing, much like naked shorting, is an illegal tactic used to destroy companies and cause their shareholders to lose a significant amount of their investments.[46] Oftentimes spoofing and naked shorting go hand in hand.

One doesn’t illegally manipulate NWBO’s stock price thousands of times in a vacuum. There is likely a significant naked, unreported and/or underreported short position that is being protected by the Wolf Pack.

Firsthand View of an Extensive Social Media Distortion Campaign

What’s one way to protect a significant naked, unreported or underreported short position in a company whose stock is largely held by retail? An unrelenting misinformation campaign. Enter an online stock message board like InvestorsHub (“IHub”) with thousands of different investment forums. IHub has approximately 8,800 message boards for US listed companies, 12,984 boards for the US OTC, 2,131 for Canadian companies and 917 message boards for other markets.[47] In total IHub has approximately 24,832 message boards.[48] Out of these nearly 25k message boards, NWBO is and has been for over a year, the #1 most read and posted on forum at IHub.[49] This isn’t just a one off. NWBO wasn’t the most posted on and viewed board for a single day, but nearly every single day, for years on end. On an average day, you can look at the NWBO IHub board and see the same regurgitated negative narratives often containing false and/or misleading information. These negative narratives are an attempt to drown out any positive discussion.

What does a typical IHub poster on NWBO’s message board look like? Let’s take a look at Exwannabe (“Ex”).[50] Ex started posting on NWBO’s message board in 2014 and is up to 12,183 posts as of writing this article. He posts on weekends, weekdays, and at all hours of the day. Ex has, on multiple occasions, pointed out that he owns no shares of the company. Ex’s posts are always negative, often misleading and sometimes downright false. Ex claims he has been on these boards for nearly nine years and 12,000+ posts because (1) he found the company interesting, (2) he finds the NWBO supporters disgusting, (3) he wants to set the record straight and (4) he loves watching a good train wreck.[51] Could this lone poster just be a white knight that decided to dedicate a large portion of his life to helping the poor retail that invested in NWBO without any financial incentive to himself or herself? Sure, it’s possible, but unlikely, given the very negative comments he has made about NWBO longs. Now, throw in another 20+ Exwannabes that post on the same NWBO forum using the same reasoning for posting. Are the poor NWBO retail investors the luckiest retail investor base on the planet with so many white knights at their disposal or is something else happening here? Enter Poor Man and his team of supposed white knights.

Who is Poor Man? Poor Man is an IHub alias born on October 30, 2015.[52] Poor Man, as of writing this article, has 7,546 posts on NWBO’s message board and 205 posts on USRM’s board.[53] USRM is the stock symbol for U.S. Stem Cell, Inc. This is important for later. Much like Ex, Poor Man has an overwhelmingly negative slant to his NWBO posts on IHub. In August of 2022 I engaged in a private conversation with Poor Man on IHub.[54] It was a colorful conversation.[55] At one point Poor Man wrote to me stating, “If you want to work for short sellers, let me know.”[56] Poor Man went on to state “I helped bring the stock price down and got them delisted. So I’ve already received my bonus. Everything else is just small change at 68 cents. 7 years ago this stock was $10…”.[57] Poor Man also said, “Even if my team doesn’t drive this to zero, we’ve already made a fortune!” (Figure 4).[58] Another relevant tidbit was where Poor Man stated, “My team has already received their bonuses for their work on this stock.”[59]

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Poor Man stated that he works with a team on behalf of short sellers to drive the NWBO share price to zero. Perhaps Poor Man has simply been messing with me, a favorite ending statement of his reads, “And remember, everyone is lying.” Initially, I didn’t think much of the Poor Man conversation. That is until I became aware of a case filed on January 28, 2016 in the 11th Judicial Circuit, Broward County, FL, Case No. CACE-16-001616.[60] Remember where I said we would be circling back to USRM, or U.S. Stem Cell, Inc.? They are the plaintiff in the case. The defendants were aliases on IHub and Yahoo message boards including the same Poor Man currently still posting at IHub.[61] The Plaintiff believed Poor Man might have been working in concert with multiple people to publish disparaging and defamatory statements about USRM on the IHub message boards with the purpose of bringing economic loss to USRM (Figure 5).[62] It's important to note the case was dismissed on procedural grounds. The Court didn’t have personal jurisdiction over Poor Man under Florida’s Long Arm Statute. Therefore, the case was never heard on its merits.

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Poor Man apparently has a history of trying to destroy largely retail held stocks through disparaging and defamatory statements on social media. Despite this history, which IHub was made aware of when they were served with a subpoena in this lawsuit, they recently made Poor Man a moderator of its’ NWBO message board.[63]

What happens, as in my case, when you don’t fall in line and join the misinformation campaign? Let’s take a look at my interactions with Legend431 at IHub, or murcidencel11 at X, or catmeadowlands at X, or crashoverIHub at X – all the same person. Apparently, they stick the goons on you to try to intimidate you into silence. I have received phone calls which I eventually realized (after letting the entire message save to my VM) were from prankdial.com. I have received numerous threatening messages in private messages on both IHub and twitter, with some of them shown in Figure 6. The personally identifying information has been redacted in Figure 6 and my notations are in red. My home address has been posted publicly on IHub at least twice. My cell phone number has been posted on both IHub and X. My wife’s name has been posted on IHub. There have been requests to meet at a bar next to my house so we can “hash things out”. A sampling of some of the messages can be seen below.

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There is a reason NWBO is the number one most active message board on IHub and it isn’t because all the traffic is organic. This is a smear campaign on steroids.

Final Word

The Wolf Pack appear to have made a large bet that NWBO would fail, consequences to GBM patients be damned. There was a time where it looked like they might be right. NWBO had to pause their trial for roughly two years as they ran short on funds. Despite the hurdles, NWBO has now wrapped up their trial and are close to regulatory agency submissions for approval. The overwhelming daily negative social media narratives are an attempt to drown out NWBO’s good news.

I don’t know for certain whether this overwhelming negative social media presence is there to protect any naked, unreported or underreported short position. Maybe this is all organic discussion. Doubtful, but I don’t care. NWBO isn’t a meme stock. This isn’t a fledging movie theater chain that is losing audiences to streaming apps. This isn’t a brick-and-mortar gaming store when everything is moving to online purchases. NWBO retail longs don’t invest in a company for the squeeze despite underlying concerns in said company. NWBO is the opposite. We invest in NWBO for the underlying company. If a squeeze happens, great. That’s karma for betting against a treatment for long suffering cancer patients. If there isn’t a squeeze, great. NWBO will find success either way.

DISCLOSURES: The author of this article holds shares in NWBO. The author has received no compensation in connection with this article. This is an opinion piece. The information in this article is for informational purposes only. The information contained herein should not be understood or construed as legal, medical or financial advice.

[1] Association of DCVax-L With Extension of Survival Among Patients With Glioblastoma

[2] Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer - Full Text View - ClinicalTrials.gov

[3] Id.

[4] www.nwbio.com

[5] https://ascopubs.org/doi/full/10.1200/JOP.2017.025536#:~:text=The current standard of care,year survival compared with treatment

[6] Id.

[7] Id.

[8] About Glioblastoma - National Brain Tumor Society.

[9] www.nwbio.com

[10] Id.

[11] Longer-term (≥ 2 years) survival in patients with glioblastoma in population-based studies pre- and post-2005: a systematic review and meta-analysis - Scientific Reports

[12] https://www.ncbi.nlm.nih.gov/books/NBK469987/

[13] The clinical trials landscape for glioblastoma: is it adequate to develop new treatments?

[14] Effect of TTFields Plus Temozolomide vs Temozolomide Alone on Glioblastoma

[15] Association of DCVax-L With Extension of Survival Among Patients With Glioblastoma

[16] Id.
[17] Northwest Biotherapeutics and Advent BioServices Announce Receipt of License for Commercial Manufacturing at Sawston, U.K. Facility - Northwest Biotherapeutics

[18] Big Biz Show - 07.14.2023 by Big Biz Radio Show

[19] Inline XBRL Viewer

[20] Id.

[21] Dendritic Cell Vaccine for Patients With Brain Tumors - Full Text View - ClinicalTrials.gov

[22]

[23] Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma - Full Text View - ClinicalTrials.gov

[24]

[25] Spoofing (finance) - Wikipedia

[26] Id.

[27] Id.

[28] Northwest Biotherapeutics, Inc. Securities Litigation | Cohen Milstein

[29] https://www.cohenmilstein.com/sites/default/files

[30] Id.

[31] Id.

[32] Id.

[33] Id.

[34] Id.

[35] Id.

[36] Id.

[37]

[38] https://www.cohenmilstein.com/sites/default/files/NWBO v. Canaccord Amd. Comp. - Exbt. 1 - 04102923.pdf

[39] Twitter.com/midwesthedgie

[40] It took years, but the failure of Northwest Bio's brain cancer vaccine is now in the open

[41] Northwest Biotherapeutics, Inc v. Canaccord Genuity LLC, 1:22-cv-10185 - CourtListener.com, Document #115

[42] Id.

[43] https://www.washingtonpost.com/busi...b99b0a-4507-11e4-b47c-f5889e061e5f_story.html

[44] Id.

[45] https://news.bloomberglaw.com/banki...-traders-sentenced-to-one-year-for-spoofing-1

[46] https://westviewnews.org/2023/01/23/our-capital-markets-are-under-siege/james/

[47] https://investorshub.advfn.com/boards/hubstocks.aspx

[48] Id.

[49] https://investorshub.advfn.com/boards/most_post.aspx?p=d

[50] https://investorshub.advfn.com/boards/profile.aspx?user=81442&page=347

[51] https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172442036

[52] https://investorshub.advfn.com/boards/profilea.aspx?user=546046

[53] https://investorshub.advfn.com/boards/profileb.aspx?user=546046

[54]

[55] Id.

[56] Id.

[57] Id.

[58] Id.

[59] Id.

[60] https://drive.google.com/file/d/1BnnP3lqZoG7GS0-SIWjXl7UfXlkL5_my/view?usp=sharing

[61] Id.

[62] Id.

[63] https://drive.google.com/file/d/1t_XDHaYhSM_dxL_iIpLJJZW89FIV8J9s/view?usp=sharing
 
仅仅两天底部横盘?或触底反弹?需要增加交易量来证实。

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Finally a bit of transparency both longs and shorts have been yelling for, a news release for all to put their bets on table, including naked short wolfpack.

It seems NWBio will formally submit MAA to UK HMRA for marketing approval of DCVax-L vaccine for GBM no later than 14 October, and if the company's request for 150-day priority review is granted, then we will get approval around March 2024 if not sooner, depending on how the review process actually move. [In average, MAA applications under 150-day priority review get approved in about 90 days, so if we repeat the average, we could get the vaccine approved around Jan/Feb 2024. In the meanwhile, I don't think NWBio will wait until after approval from HMRA to submit applications to other regulatory agencies such as US FDA; There will be other positive activities as a result of this news, formal application, grant of priority review, and approval, such as combo trials with BPs, partnerships, etc.]

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最后编辑:
Not specifically sure about that. Some posters on iHub or tweeters reported that. It's true though the date given is usually called action day, meaning the regulatory agency will act on decision no later than that day, so the vast majority of applications are approved practically before "the action day." In our case, if priority review is granted it will be no latter than 150 days. Considering extensive consultation and communication between MHRA and NWBio, and considtnetly favorable UK regulatory environment toward DCVax-L, DCVax-L may get approved much sooner than 150 day deadline, but how soon will be anyone's guess.

For longs who have waited for years, I don't think it makes a big difference. GL!
 
The road ahead may still be bumpy without major institutions support, but at least we now know the road map for approval in UK. After UK approval, it will be a tsunami of approvals elsewhere and positive activities everywhere.

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