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Shorts are about to be thrown out of the bus, having endless sleepless nights in the order of
a few retail shorts, legal countable small-mid size short hedges/entities, big and shameless naked short hedges/MMs
I am counting the days increasingly with amusement!
UK MHRA approval is just the beginning, a huge validation and a substantial revenue injection.
10-1000 times market potential follows!
All are correct but to be exact: instead of "they’re in the final stages before approval" it is usually the last step of the final stage before approval. RAs normally would not clear manufacturing readiness inspection if there are other issues outstanding.
Now that UK MHRA inspectors have been back to office and checked the manufacturing readiness, it will be very soon for them to issue approval.
Must have been that unless MHRA is well overstaffed, has nothing to do.
This means we are on track for approval any day now. No inspection no manufacturing authorization. So inspection on manufacturing readiness has been successfully done. Share price rises tomorrow. If not substantially, I will be pleasantly surprised, which means I would buy/add substantially. No time to wait, it's only days away maybe, at most a month away!
It might just be because of this video on 26 Aug that had convinced one or two investors to get in big, taking out all the asks during their buying spree. However if Scoth doesn't understand correctly what does the word puck mean, it means MMs has to puke millions of shares in these occasions, soon they will have nothing to puke after their MTD is denied and/or DCVax-L is approved. I can clearly see that day ahead.
You are absolutely right Zadie. I have added more NWBO this morning at around $0.3150 with profit from other small biotech swing trades such as CTXR (sold before it tanked), mrns just days ago. I also added ckpt, lvtx using the profit.
This fall will be golden!
Hello, I don't go reading this board anymore, and I see only two things:
MAA APPROVAL ANY DAY FROM NOW TO OCTOBER!
SHARE PRICE HAS ONLY 30 CENTS TO ZERO!
IT'S A BUY TIME LADIES AND GENTLEMEN!
Manufacturing readiness first day of approval, mass ramping up with Flaskwork Eden system months later, ready to go treating patients at 80+ medical centers.
Desperate MMs and naked short hedges and corrupted market in general make our dream richer and more attainable in short time after decade plus of "blood, toil, tears and sweat!"
Yes as I posted on 17 August:
"In risky small biotech investing, it doesn't matter much on what is one's successful rate, either 60% or 10%; what matters the most is the decision on the weighting of one's investment on one or a few which would be eventually very successful and rewarding.
It's already extremely difficult to locate a successful company, let alone deciding the weighting on a specific company. Often time knowledge and experience would make a difference, but equally importantly, we do need some luck if we have put a hefty weighting in one or two companies.
So here is my prayer for the success of NWBio in its cancer fighting cause, its long-awaited profitability, and for a unprecedented property for its investors !
It's not a gamble, after years of "blood, toil, tears and sweat" of all good people to discover the science, conduct the clinical trials, fight the evil forces, success is finally near!"
Please grab the opportunity to get rich! Set you sight only on that, not the usual noise! Besides how long is days, weeks or a couple of months anyway?
Next trading day will be 26 Aug falling into my earliest approval territory so countdown starts next week. BTW WTF were all those more than a dozens of 2.5k lots traded at $0.384 in less than 30 seconds.
08/23/2024 16:00:00 0.384 0.00 2,500
08/23/2024 16:00:00 0.384 0.00 2,500
08/23/2024 15:59:59 0.384 0.00 2,500
08/23/2024 15:59:59 0.384 0.00 2,500
08/23/2024 15:59:59 0.384 0.00 2,500
08/23/2024 15:59:58 0.384 0.00 2,500
08/23/2024 15:59:58 0.384 0.00 2,500
08/23/2024 15:59:58 0.384 0.00 2,500
08/23/2024 15:59:58 0.384 0.00 2,500
08/23/2024 15:59:58 0.384 0.00 2,500
..........................................................
Rumor? No! I would say it's an educated and experienced prediction:
The fact INSPECTIONS had been scheduled as of late July/early August; MIA license issued last year by MHRA suggesting there would be no need for manufacturing inspection for MAA approval, and manufacturing readiness is usually the most complicated and the very last step before regulatory bodies to approval an application.
So a reasonable prediction for MAA approval comes late this month as earliest and in October the latest.
Any shorts who actually play their own money would not dare to hold and would naturally cover; on the other hand anyone who know NWBO would either add or start a new position in anticipation...
As far as the corrupted and accused 7 MMs and the naked short hedges, they can either fight their increasingly more desperate fight to the end or stop at anytime or after their MTD is denied.
Here we go on the uptrend north. And any pullback is another opportunity to add and buy.
In risky small biotech investing, it doesn't matter much on what is one's successful rate, either 60% or 10%; what matters the most is the decision on the weighting of one's investment on one or a few which would be eventually very successful and rewarding.
It's already extremely difficult to locate a successful company, let alone deciding the weighting on a specific company. Often time knowledge and experience would make a difference, but equally importantly, we do need some luck if we have put a hefty weighting in one or two companies.
So here is my prayer for the success of NWBio in its cancer fighting cause, its long-awaited profitability, and for a unprecedented property for its investors !
It's not a gamble, after years of "blood, toil, tears and sweat" of all good people to discover the science, conduct the clinical trials, fight the evil forces, success is finally near!
Let's talk about some trivial things of NWBio which have never gong to the press, and one can only find them either in the fine print of an SEC filing, or in the discovery of an enthusiastic investor, and often in a way afterward as if they were truly trivial or even negative so the company has gone a long way to "hide" them.
On the other hand, such trivial things are usually treated very significantly by all other small biotech companies who would eagerly have them PR-ed, with some saw substantial rise in their share prices afterwards.
In NWBio's case, information such as patent applications, patent issuance; expanded clinical trial pipelines either owned directly or indirectly as beneficiary; all are missing in NWBio's official website which is not only insufficient with missing information but also antique as if it might need an archaeologist to discover, examine and value for the mass.
Where are the patent portfolio, where are the added clinical trial pipelines ... Wondering what else has DI been doing besides taking some phone calls from angry investors? I know lots of small biotech companies run by even smaller size of two or three persons all have very modern, professional and users friendly website. why not us?
All that has added is just one more reason for the saying: buy as many as you can afford at this level of price and time, before the long-live NWBO has not yet been discovered or unearthed.
Forget upcoming MHRA approval, which will floodgate open for other RAs approvals such as FDA, EU,, followed by approvals of other indications most certainly because of the same shared MOA. Then, the beauty of combinations suggests cures for solid cancers not just improvement... am I drinking too much in such early in the morning?
Forget the accused mighty MMs who will have to pause in manipulation while coughing up very significant sums by each or face discovery of even wider, deeper, dirtier and much more destructive committed acts which will be severely punished.
Be a living legend ladies and gentlemen, there are enough reasons to own this stock before it's unearthed.
Well it will be a few very interesting and exiting weeks ahead with summer heat and AC cool. One share bought means one share short for the already very short shorts.
It becomes even difficult for my champagnes to not pop!
MHRA approval for both n-and r-GBM; MTD deny; institutions competing for shares we hold; Linda pulling a rabbit or two, who knows.
The very ultra depressed share price is a risk or danger for the short and the corrupted but a steal for who can afford to buy,
Let them bring it on!
[Intended for reply to norisknorewards] He is actually such a simpleton that he thinks he is the only one who is savvy and experienced enough to invest in nwbo throughout all his posting history.
Well it's obvious who is the laughing stock actually, with faked french accent or not.
Dealing with persons of such personality all my working life; better not giving the attention to who desperately wants.
Cheers
you are right on what you have reported, because it's a fact with the link, but you are deadly wrong to suggest NWBio will be in Feb 2024 to get approval as the earliest.
Statistics needs not to be expanded where you have specific information and knowledge of how the process is contained.
In our case, the fact is now we know inspections had been scheduled which is announced in late July/earlier August, and most likely the most complex and most time-consuming step of manufacturing readiness for approval may not be necessary as I said in my previous post for reasons readily understandable. [we got a MIA license last year]
The fact is the inspection for manufacturing readiness is 99% the cases the last step in the approving process.
Thus my earlier suggestion that we may get approval in late August 2024 the earliest and in October 2024 the latest.
As I said, massive investors including institutions are on the road competing shares as we are so close. And the smartest are already stealing the shares.
Cheers
[this is my last post for today]
Where's the Beef literally? Instead nothing in their recent filing. I think it's a good thing as SIO a mid-size jerk finally found its position as nonresistant to the corrupted we have had the chance to load more shares at lower price.
As I said, they are on the road to compete shares we have had accumulated in the low range. Not just institutions, massive potential retail investors, but the burning on fire shorts.
The days are coming.
Re manufacturing inspection and SIO:
On 30 March 2023, NWBio announced MIA license for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K was granted by MHRA. The license covers broader cell therapy products than just DCVax. So I don't think it's necessary MHRA would do an inspection again for the purpose of approving DCVax-L for n-and r-GBM.
So approval may come earlier than expected, definitely much earlier than in October.
As I said a few days ago, SIO from any angle is a short by practice not a long we initially thought. Probably under the pressure of the "mighty" 7 accused MMs. So we have none of long institutions as of two days ago when share price was suddenly let out of the bound.
As approval decision by MHRA is very close and rude awakening for the market is just around the corner which will be triggered by denial of the corrupted MMs' MTD with the general market now realizes recession is still far away or none, a tsunami of competing new longs are on the road.
Next is who has the bragging right to get in the boat the earliest at the lowest price. As for SIO it's a history!
Cheers for the low price all the way to approval.
https://nwbio.com/northwest-biotherapeutics-and-advent-bioservices-announce-receipt-of-license-for-commercial-manufacturing-at-sawston-u-k-facility/
Having been saying this for quite a while: It's most likely DCVax-L will be approved by MHRA later this month the earliest and by October the latest for two indications (not one), nGBM and rGBM, as a novel revolutionized scalable and expansible cancer vaccine, not like most approved so-so drugs/vaccines or tricky formulations of other people's already approved drugs/vaccines.
The impact and market potentials will be huge and it will be difficult to fool the mass by any tricky corrupted market makers or short hedges.
With flaskork Eden systems onboard within a year, there will be no cracks any naysayers can make use of denying its huge market potential.
And we will be very busy with artisan manufacturing in the meanwhile before Eden systems are massively used.
I don't want to give my target on how big the market potential will be, but I am extremely happy I have accumulated more than enough shares than 99.9% of th retail can imagine.
Once again, I also prepare to get even deeper if necessary, fully expect for a possible bumpy road ahead, but happy.
This is exactly my understanding when I first heard his talking, but unfortunately got swept from a tsunami of misunderstanding which in big part was due to Les's loose talking in the first place.
I strongly believe the following statement is true and what Les was meant to say at the time:
"Les told a friend at the ASM that the “fall” comment was a misstatement. He says he meant that by late fall all the things they’ve put together will make this a completely different company when they all fall into place. He didn’t mean to refer to MAA approval. "
I hold my opinion that MAA approval will come late this month the earliest and late October the latest.
Thanks for posting this.
The status in regards to where we are is simple imho. I think INSPECTIONS are about to happen or already ongoing according to the recent 10Q. Note: on the subsequent events section in the report: none. So MHRA approval should come later this month the earliest or October the latest.
Share price will react accordingly as the market is awaken and in anticipation for approval.
Share price will be further stimulated anticipating MTD deny as the accused will be the first to know that before the general market does.
Short squeeze believe it or not will happen. The only thing uncertain is the magnitude.
Buy as many as you can afford, go take a vacation!
[this is not intended for reply to maverick but beartrap12]
What a hack you wrote, "I believe MHRA needs to see that our Flaskworks Eden units work before we get a green-light for MAA." You are totally out of bounds against all NWBio has stated so far and against a regulatory process which has been clearly specified.
Overly enthusiastic, cart before the horse is no less harmful than the short bizarre baseless slanders to the interests of NWBio, its investors and yourself as a long (maybe a radical long TO BE EXACT).
Please stop. Let the process play out according to the course. MHRA will approve MAA with manual manufacturing, then improved Eden systems will follow.
Unless you stated that on behalf of the company, preparing us for one more delay, which I don't think is the case, cause Linda though selfish and greedy is not that stupid.
So please all overly enthusiastic longs STOP!
Quiet before storm!
It's in a pre-clinical trial. What competition?
https://www.cytodyn.com/pipeline
Very happy to add a lot of shares the last week as I had firmly believed we are close to approval, literally any day now. From the 2nd Q report, it spells out literally just that. Many investors just don't have the experience about how the approval process will be unfolded so now the 2nd Q report spells it out for you: we may be well within the last 70 days of the approving process.
No doubt, the shorts know that very well but just act otherwise. In paid social media and in manipulated trading as long as the demand is not significantly enough, it still seems we are far away from approval or as some actors say approval in 2025.
The warped market by corrupted 7 market makers and naked short hedges will be straightened when the market is free when DCVax-L is approved and the manipulated MMs are denied of their MTD. It's a state of dictatorship in NWBO trading that I suspect even the first and initially seemed to be long institution SIO may end up a short element due to pressure from the mighty corrupted 7 MMs. In this affair, either you are with us or against us. SIO is just a small fish who no guts to say no to the mighty corrupted.
All the above leads to where we are today in terms of price, which is exactly why I have been accumulating.
Cheers!
So the market doesn't believe NWBio will receive UK MHRA approval in coming days/months for a paradigm shift cancer vaccine, not a so-so drug/vaccine or a drug/vaccine in a crowded market?
So the market doesn't believe the unprecedented price manipulation will be abated if not stopped when and after the seven spoofing MMs are rendered denial of their outrageous MTD?
So the market doesn't believe after the approval, the door will be open for multiplied approvals in new indications in many other markets in the world?
So the market doesn't believe after the approval, the door will also be open for leap and bound improvement, if not cures for cancers with combination trials, followed by expedited approvals around the world?
So the market doesn't believe, judged by the intensity of social media army of bears, scammers and outright liars paid by manipulating MMs and hedge funds or anyone who will be benefited if we fail, the future values of this tiny company will be enormous if we overcome the first hurdle of approval in UK?
I am a strong believer for more than 10 years, and also believe because of the above, the share price is a steal. So I am a buyer, particularly at today's price.
I don't know what you think, but it's a simple math and physics and a bit of logic for me that the price will most likely go north as the approval process is known to be in the final stretch: after inspections, it's approval; no other way around.
The math says the price would only have 30 cents to drop while a blue sky higher to fly; the physics says the price has been falling for so long a time so that now it's like the last mile in a marathon to fall but a 5-km race if not a 100-m sprint race to go north.
The logic says the long-awaited approval would come shortly after inspections. It's fucking palpable like a baby kicking in the womb that a new birth would come in the near future.
For those playing with fire for so long would definitely get burn now with denial of MTD like fuel in the fire burning these bastards real hard.
Buy as many as you can afford. I have done that and would do so before approval.
Why the sudden a rash of restrictions on buying nwbo shares in multiple countries, even in the us in a lesser degree after so many years trading OTC? why now?
Yes, Stuttgart is a recognized exchange in Canada, but your statement based on your CRA conversation suggests Stuttgart also operates the way of OTC? So we may suppose Nasdaq may also operate alternatively OTC? which is not the case.
What I heard from investors in Canada is that early this year around April or May, there are determined "investors" who kept poking around brokerages and CRA on this tiny biotech stock. As a result, after traded OTC for more than 7 years, now and only now NWBO has been deemed non-qualified or restricted as price kept falling for a long stretch and approval is on the horizon. It's reasonable to believed all the fuss restricting nwbo trading out of blue now must have had something to do with the manipulating forces, which probably related to one or two or more manipulating MMs, because they are closely related to the brokerage houses and banks of the countries concerned.
We have suddenly drawn the attention of various kind of actors, posing as investors, patients, and you name it.
[reached my post limit for today]
Who told you inspections are for reviewing trial results at trial sites and has nothing to do with manufacturing? It's because it involves US?
Logic thinking is that inspections are the final stretch in the approving process as we are already so late in the game, which reviewing manufacturing readiness is the major part.
No reason to think otherwise.
Hank, who told you that. Stuttgart is a recognized exchange in Canada, and who told you Stuttgart trades stocks in the fashion of OTC?
TD Direct Investing and CIBC Investors Edg, etc all said it's CRA who ask them to limit NWBO trading in registered retirement/tax saving accounts, etc while CRA said it's the brokerages who determine which stocks are qualified or not according to the rules.
So I strongly suspect this case in Canada, and other similar cases in Denmark and Holland are all the work of the corrupted MMs aimed to depress the share price, etc.
Yes they are different. I believe Linda will go big or home for this case. I guess if they don't want to be ever more notorious and disgusted by the mass, they will settle after MTD denied.
If I were Linda, any sum below $1 billion is out of question. We will know more later.
It's palpable the short are dying better slowly than quick as the last stretch of approval reached and the seven MMs stock price manipulation of a small biotech with paradigm shift cancer fighting vaccine platform is about to be known to the public with denial of MTD imminent.
The hole the MMs and the short have dug is so large and deep that there is no sky to see but darkness; However hard they have worked is unfortunately bounded in the dark, already detached from reality.
Thus in days ahead, the less resistance, the less suffering for the short; the more resistance, the more gain for the long, the science and patients.
Nothing go a straight line, but we are heading in the direction of compass: imminent approval of a revolutionary cancer vaccine and justice serving denial of price manipulating market makers.
With that, the opportunities and prosperity are boundless!
Inspections usually take one to two weeks of which manufacturing readiness is of the most complex. Since our manufacturing just freshly inspected last year with a commercial license issued, I would bet inspections in our case may take a maximal of a week, and I don't expect there are any major questions raised if there ever is any. So I would think approval could be issued any time after a week of inspections, ie, approval may come as early as later this month, or September. Les may be for the first time underpromise but overdeliver.
KEY WORDS: INSPECTIONS ARE SCHEDULED! IT MEANS THEY WILL HAPPEN IN NEAR FUTURE.
LINDA LEAVES SCHEDULED DATE INTENTIONALLY OUT.
From Today's 8k, Item 7.01, "Meanwhile, we are continuing to focus on working with our teams of consultants on activities related to the review by the Medicines and Healthcare Products Regulatory Agency (MHRA) of our Marketing Authorization Application (MAA) in the UK, including preparations for inspections by the MHRA that are scheduled to take place in both the US and UK [left out: in the week of xxxx]."
[
Zadie420, I have reached my three post limit so I reply to your post here:
My understand is that inspections consists of site visits, manufacturing visits, etc. Inspections in US may be trial site visits, not including manufacturing. BTW, inspections, particularly manufacturing one is the last step in the proving process. Cheers]
Hi moreisless, I put money where my mouth is. Believe it or not I think now is in the bottom area. How about you? Talking is cheap, are you in a short position? Or can you say to the God you are not going to buy any NWBO shares as your breath is always foul.
At least I replied to your post. Take that as an honor!
[as start for today at opening, 8k added at 0.318. It seems I can add more below that price. bye now]
I am back in the buying mood again, simply because it's that time again in August for general languishing stock market, particularly for high tech sector which all are in bloodshed, exacerbated by fear of recession as Fed acts too late for rate cut, and more importantly we are in any of that days territory for UK MHRA approval.
Okay, it may not be exactly the point of bottom, but I am positively sure NWBO price is in the bottom now. Buy as many as you can afford, trying not thinking the selfish and greedy Linda and the gang, let alone the naked short wolfpack, and the manipulative MMs.
Cheers
Given the state of despair in terms of daily declining price on the eve of fate-changing news of either MTD denied or HMRA approval, Linda and the management should publicly announce their stance of truly on the same boat with the vast majority of retail investors BY GIVING UP ONE HALF OF ALL THEIR WARRANTS AND OPTIONS.
It's highly hypothetical or rhetorical but the only way to move forward in a justified way facing the fierce battle with the evil wolf-pack naked short forces, and manipulating MMs before news.
Shame on all those pity retails and island boys who have encouraged and rewarded the management for their unsatiated greediness for so long by giving them unimaginable numbers of ultra low price warrants and options.
The naked shorting wolf-pack and manipulative MMs will one day face justice, no doubt, but the management's selfishness and greediness has also to be stopped!
I don't know the reason why you guys continually entertain the board with back and forth with the obvious pathetic 50 cent earners for the naked short wolf-pack, let alone a few short loners of village-level intelligence.
I have been as promised busy adding shares -- just the last 7 days about 150,000 shares added. With well over 7 figures of shares, I think I have had enough --- Wolf-pack please continually manipulates it down, displeasure me.
Right now two big issues are imminent to happen: MTD which will be most likely denied, and MHRA approval -- in days or months, which the market perceives as negative artificially via manipulation while the savvy takes it as golden opportunity, or even a steal to add shares.
Furthermore, as I said week(s) ago, it's now the time for small cap to shine, particularly small biotech as the great rotation from Tech to small cap ongoing. So besides NWBO, I have also add other small biotech, such as CTXR, LVTX, etc.
I have averaged up from as high as $1.6, and yesterday as low as $0.37 with an average around $0.3. Pretty happy about the whole pile of shares, shining from not far distance.
Besides, has Linda mentioned at ASH meeting, there have been other activities ongoing. So one or two unexpected news may be about to pop, particularly the bid phamas now feel the urgency to close deals.
Now I shall forget what I have held, awaiting patiently.
Cheers
It's small cap time, particularly for small biotechs as big $ roll out of the magnificent and high running sectors and in general big caps, with FED pause for the first rate cut in coming month.
A few other small biotechs I bought all have run up recently. When NWBO's time arrives, it will run up with roaring sound!
Added more.
Cheers again!
He was talking about half truth as a long just as the intelligent short always does.
In regards to patients personal level data, as long as ECA is concerned, no company seeking FDA approval using ECA would never have that kind of data unless the data are readily available within the company, because patients personal level data is always proprietary. They will never share, particularly from the standpoint of competition.
Linda choosing MHRA as the first RA to approve simply is for the reason of their good cooperative relations, the manufacturing site availability, and the desire of UK to lead after Brexit, etc., which doesn't mean there is problem for FDA to approve. Of course, if MHRA approves, then it becomes easier for FDA to do the same, and vice versa.
On the other hand, Linda and the team should not take this for granted, corruption like a disease can infect anyone in anywhere. So if Cofer Black has nothing to do, he better check those UK MHRA assessors for possible infections.
The naked short wolfpack is a very contagious virus. Linda and the team must be aware and alert.
Cheers
For God's sake, do you know what condition does Outlook's approved product treat, and what will Northwest Bio vaccine treat if approved?
And the price of each treatment, the market potential?
I tell you at MC of between 100-200 millions Outlook is fairly valued in my opinion, but what MC would you give to Northwest Bio if DCVax is approved?
You guys are just talking heads. It's dangerous to invest with that kind of mindset!
With regard to where our MAA status is, or in which stage of the three stages consisting of the initial 80 days review, then in most case a 60 days of clock off, and lastly 70 days of further review and decision, any guess for MAA approval from next Monday to any further day after that, including later in the fall, or by next year is warranted, which is exactly the goal of how Linda would have structured her statements regarding this matter.
So the background or the fact is 1) Linda/NWBio would not give a clear or specific information to the public regarding the status of this MAA; instead she would only PR approval after it happens, and the company would not pr anything in between; and 2) the inspection will be ongoing throughout the whole process.
So let me interpret what Linda has said during ASM yesterday. She said, "NWBO continues to prepare for inspections including questions and any request for information the MHRA may have." --- now one of my interpretation: yes although inspections have happened and completed, we continues to prepare for [further] inspections including [further] questions and any request for information the MHRA may [still] have since "the inspections will be ongoing throughout the whole process."
My real sense is inspections/visits to selected clinical trial sites, and any questions and requests for information arrive from that is completed with inspection for manufacturing readiness outstanding, which may have actually happened, but if it is indeed outstanding, the inspection would be very easy to pass, fresh off NWBio being awarded MIA not long time ago by the exact same MHRA. So I would think this process is redundant.
So at the end of the day, anybody has his/her opinion regarding when MHRA would approval DCVax-L and surprisingly anybody is right as of today, which is exactly what Linda would pass around.
Note Linda also said during the meeting, we believe MHRA is following the 150-day process but no confirmation of that yet which I can also interpret her statement as MHRA is following the 150-day review process, but since we have passed the 150 days and have not received approval yet, so there is indeed no conformation as of today.
Com'on, let the short be tortured not our long since we are determined to see this company success, not only in securing MHRA approval, FDA approval but much much more down the road in years ahead.
I like franchise. I like expanding management. I like this company partnering with others,. I like this company grows stronger year after year, generating gains for its shareholders. Now I dislike buyout. If that happens, I have to pay a huge tax.
Cheers