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Hi Doc et all,
Once the company receives the data from the statisticians, approx 2 weeks after DL how long would they have to inform investors of trial failure if both endpoints are not met. I seem to remember that this disclosure has to be made within days per SEC reqmt. My thinking is that the company said that they would need to consult over the data for approx 2 weeks before releasing topline, so once the 2 weeks from DL are up and we hear no initial news of trial failure surely greater and greater pressure will be felt by those nefarious forces opposing this technology.
The 4 week timeframe has always interested me and my thinking is that if there is a potential partner moving forward this month gap is the perfect opportunity for both parties to thrash out a deal of some sort.
Here is an interesting page regarding obligations of companies per their investors.
[url]https://westwicke.com/2019/11/keys-to-successful-disclosure-of-clinical-trial-data-and-milestones/
Well said, patience is indeed key and to all those who may keep an eye on this board, some active some passive, know that we few investors out of the billions of souls who inhabit this true miracle of the stars are so very close to watching a new awakening in cancer care that will have such a beautiful impact on extending the lives of so many now and into the future. It is time for so much hope to be realized. Eagerly and patiently awaiting NWBO’s awakening. GLTA.
Having lived the first 35 years throughout Africa and receiving every vaccine under the sun, I can attest that I have hardly ever had a cold never mind the Flu. The years I did live in Europe sporadically during this time I remember many people getting colds and flu's around me but I was unaffected. I have now been in the US for the past 15 years and have never taken a day off work due to cold/flu. Hopefully this remains the case with this strain of corona as well.
Showing your true colors aren’t you JC. It is so easy for people to preach on hindsight.
I am sure this companies relentless approach to achieve approval of a paradigm shifting technology against all the odds in a world ruled by maniacal money men intent on total control of the cancer field will be lauded for years to come.
I believe science will win the day and benefit so many more future generations instead of its technology being snatched by greed only to be stored away while the system continues to feed chemicals into our systems in the guise it will extend our time with loved ones by a few months.
I have have been in the unfortunate position to witness the true devastation that current cancer drugs has on a person and believe those few extra months are just not worth it while these shameful BP’s fleece the lifetime savings of desperate people.
The many people that support the greed thesis on this board and many others need to seriously take a look at themselves in the mirror and know that in a blink of an eye their image will be a distant memory. The actions we take now will either benefit future generations or continually allow the money men to dictate the future of medicine.
We all die that is an inevitable fact and the 7 billion walking this earth will be dead within 80 odd years.
I wonder if those next 7 billion will still be witnessing loved ones being pumped with chemicals or will humans start to be more humane and start to utilize their humanity and empathy and good science to engineer truly beneficial medicines that actually will make a difference.
Looking forward to NWBO being one of those bright lights where science over greed wins the day.
You fail to understand that the number of deaths is a hard and fast number. Trying to predict how widespread an infection is, is the issue. The belief is that if everyone was tested you would see a lot more people have had this virus and the clear and simple number of deaths would not change. Obviously you need to conclude that the spread of the virus is already prevalent so extrapolating the number of infected is more relevant than the number of deaths caused by the virus. The two numbers do not go hand in hand and the number of deaths is the clear and defining number to be used as a % number of deaths to those infected which should be extrapolated if the sample was taken across the entire state.
Thanks for another superb post Bio. Nice to see MESO doing great as well.
Agree with you 100% Umibe, I was glad too see LP claw back some credibility with shareholders and the markets in general. We should see some momentum start to build after this credibility is reinforced with actual datalock announcement. Once we get to datalock the gloves are off and all the options start to open up as to IWAD points. Interesting times we live in at the moment, stay safe.
I was happy for NWBO to finally give us and the market a timeline. This should be viewed by all as significant but this timeline will only become real to the market and investors on the sideline once Datalock is confirmed.
There may still be suspicion out there that Datalock will be delayed and no real money will be committed until then. Expect the detractors to continue with their daily whining until it becomes all too real for them.
If indeed many warrants are due to expire in a couple of weeks we may see some action but I expect the price to be held down until this event has passed. Once Datalock occurs then the game is on.
Another interesting take away is that we all know how much work and money is still required by the company to get to approval if TLD is confirmed as positive yet there has been no increase in the shelf. This should be disconcerting to the detractors.
I for one believe this to be a very positive sign and could point to BO or more likely partnership soon after topline.
In the meantime I think we all have a month to build on positions if your confidence increases especially with additional PR's regarding UK and Sawston are revealed in the coming weeks.
We have been patient and that patience will be rewarded handsomely IMO.
Hopefully this technology will be available to all soon and with a possible partner in Merck this reality will be expanded into many forms of Cancer at a much more rapid pace.
Price of any biotech is absolutely meaningless until results are shown of trials. Any price action in between is complete manipulation and in some cases complete fraud actioned by an out of control wall street to the detriment of many small struggling companies. You seem so hung up on the price action which in the case of NWBO has been completely meaningless ever since the shorts dug their claws into it many years ago.
Completely right, OTC stocks and especially tiny biotechs are continually shorted as soon as any buying interest shows up. The algo's tied to these tiny stocks do not care if one of these explodes at some point because it is a numbers game and generally small biotechs trade off news or spikes in buying. This is a common practice. Most traders in these area are making money on swing trades like the one witnessed over the last couple of days. It is obvious when large trades cause little upward movement then tiny algo trades then downswing the price once shorts are in place.
Fidelity provides all the information. On the e-mail they send to vote there is a very clear link under Important Materials routed to Proxy Statement. All info pertaining to the call is contained in this document.
Yup, if TLD is not presented by the company and they waffle on about the UK specials program then it looks like their new tact would be to try and continue to prove efficacy through this program tagged onto their list of long tail survivors. TLD will be delayed indefinitely if they think it will mess with this pipeline of cash squeezed by desperate patients and the hope that they see good results. No investors should be happy unless TLD is presented in short order.
All other news is totally useless because I am sure all patients would prefer an approved vaccine that is paid by healthcare and not crowd funding.
The following posted earlier is completely bogus.
Quote:
If you wish to attend the Virtual Meeting please contact us at least 10 business days prior to the meeting at 1-877-763-1671 so that we may assist you in obtaining access to the Virtual Meeting. When calling,
please have your VIF or NAA notice available.
All investors should have received a proxy with all information relating to the asm call-in etc. These details do not need to be shared on a public forum.
If all they have to talk about is Sawston buildout and asking desperate patients to fork out for an unapproved treatment then the SP will be pounded down. The Sawston buildout should have happened years ago and if they cannot be upfront with a clear path forward to approval of DCVax which we have now been waiting for more than a year then I think this management team will quite rightly be panned. It is unfortunate that we as investors cannot be present and demand answers if they are not forth coming with real trial news.
I am hoping for so much more this time round because if what you suggest is all they will reveal then the departure of KD will signal something very negative to the market and to us long term investors.
The time for this management team to start delivering to its investors is now and I truly hope that is exactly what they do especially after calling for all investors to attend.
I for one cannot be part of questions because the only thing I expect is news on the DCVax-L trial and a clear path forward to approval. Everything else is just a chance for them to deflect.
Every question posed to this management team should not allow for deflection and only be directed at why we have not reached datalock and topline if this is not revealed in the weeks leading up to the ASM.
If we have our answers to this then we need to know what plans the company have with regards action items that blaze a path to approval in all 4 regions.
We as investors need to start seeing positive action that allows all of us and patients to start getting excited that we are finally about to cross the finish line.
So it looks like Dr Duffy’s role at NWBO was indeed a collaboration between the 2 companies because there is no way NWBO would agree to hire in someone from BP and expose him to their science only too lose him back to BP.
His new role at Merck is now Research Medical Science Director which indicates task relating to implementing new medical strategies which may point to impending DCVax integration now that he is up too speed with the technology and best path forward.
As I originally suspected a partnership with Merck is about to be put forward and the ASM will indeed be interesting. IMO
Condolences to you and your family CapO, wishing a safe passage to all through the coming months.
The funny thing about this whole Corona fiasco is that no matter what individual countries adopt this virus will continue to spread because after all if there is not a world wide shutdown implemented across the globe for say three weeks how will this ever be stopped. Many countries may impose lockdowns but at some point business will have to resume and all those countries that imposed lockdowns and did not allow for natural immunity to spread will just be infected. At some point if you are going to catch this flu you will catch it and no amount of lockdowns are going to curb the spread. What we are witnessing is a completely and utterly pointless exercise that is just delaying the inevitable.
They are hoping that this delay will allow a cure to reach the market before citizens are impacted but that would mean these lockdowns lasting until then which could be a year away.
It is amazing that countries where testing has been more successful show figures below 1% and even those are skewed because the vast majority of people that caught this virus probably showed little to no symptoms and therefore were never tested. The whole world is being held to ransom over a flu pandemic that will prove to be no deadly than anything we have seen over the years. The fallout to all those people dependent on hourly wages and small businesses in general regardless of the knock on impact to all industry will last for years. The end result will be a more impoverished society and less jobs as a whole because no doubt as this escalates many jobs across all sectors will be made redundant and never to return. Who wins in all this. Not the street that is for sure as the ever increasing wealth gap will increase exponentially after all this frenzy is finally put to rest.
They have many challenges and I have lived in the Sudan,Kenya,Somalia,Zambia,Malawi,Zimbabwe,South Africa and most respiratory issues are caused by bronchitis and tuberculosis. Diseases such as AIDS and Malaria are still a massive problem and the west could do a better job at helping with these medications. Anyway my life in Africa was a beautiful period and filled with countless adventures. I never caught the flu there was my point and flu viruses were not prevalent. Hoping corona is not an issue to add to their long lists.
Africa is not a friendly place for flu type viruses, I lived in Africa for 20 plus years and never caught a cold or flu.
With the way things are going I am sure the next NWBO PR will be one where they will be discouraging investors from attending the ASM due to Corona virus.
Looks like this may have always been on the cards.
NWBO need to release interesting meeting material asap because I doubt their will be a collective ASM this year.
185000 volume to bring the price down, as I said easy to manipulate when there is no volume. There is no selloff.
There are many teams on the OTC boards that continually look for trading opportunities with cash strapped companies. Anytime a PR comes out that spikes interest these teams will engage in walking up the price only to short it back down. It is easy to manipulate the price down once the volume dies down. This game is endlessly played on penny stocks and if many on here recognized the action they too would utilize a certain amount of shares to swing trade these endless fluctuations. The only thing holding back many from engaging in this type of action is fear that they will miss the boat when finally a real announcement is made. However, there is absolutely no reason to not make some money on these swings because at the end of the day you can either bank the money or build a larger position with house money. Nothing to fret about as we wait for the game changing action. In the meantime if we are to have any further titbits leading up to the ASM do not be afraid to swing a little as I know it will make you smile. GLA
A lot of speculation regarding the recent raise at .17c. My thinking on this is that some of the investors who were approached to finance the 4 million unloaded some of their current positions prior to deal closing which resulted in share price losing value. It would be interesting to know when exactly they were approached as I am sure we would see SP depreciation leading to the eventually negotiated price. I know that if I had a substantial position in the money and was approached to help finance I would certainly unload prior to closing a new deal, safe in the knowledge that no ground breaking news was imminent.
Still waiting for comedy central to kick in.
Hahahahahaha, up to the mic steps the first comedian. His material is so original as well. Pure comedy gold.
All I can say is that for the next 60 days life is going to become more and more 'interesting' for NWBO shareholders. Looking forward with interest to what transpires between now and April 18th because I am sure the desperation levels will produce a level of comedy not seen before.
Just had to chirp in on all the noise concerning NWBO execs not buying on the open market. My take is that these execs are privy to data that we shareholders are not and therefore cannot buy on the open market until this data is disclosed. In the meantime they quite rightly receive options.
This all points to a very positive outcome in 2020.
My vision on this stock is 2020 so a very Happy New Year to all.
Breaking my silence for this one message as my better half has told me that I am an NWBO addict.
Would like to thank all those contributors who go above and beyond to help all longs on this board and wish you all a very Merry Xmas and a beautiful New Year.
I have a feeling that 2020 is NWBO’s year and the 2020’s a great decade in humanities fight against this dreadful disease.
I am like NWBO. I have gone silent, I have nothing to share and nothing to say. I sit in the audience waiting for the curtain to raise. What’s behind that curtain will answer all our questions. The show is TOPLINE.
The very fact that NWBO are willing to engage in such a forum speaks volumes after so many years of silence on such airwaves. Such engagements must point to a growing confidence that results are at hand.
Agree with all your instincts and as you say we long term investors are allowed to speculate every now and again especially seeing that we have been swimming against the tide for so long. We can all feel the shift in the tide and a beautiful wave is forming behind us that will hopefully carry this brilliant little company to a position where it can make a very real difference to so many lives stricken by this deadly disease.
This hire is looking more and more to me like a strategic placement made between 2 collaborating parties. As I stated earlier I would not rule out a partnership post Topline and who would now bet against that partner being Merck. This announcement will be confirmation to many people on the sidelines that Topline is imminent and I would expect an increase in accumulation and if those shares become harder and harder to come by then we should see a nice SP appreciation. Time to sit back with my popcorn to watch the show, it should end up with that Kobe steak that Mav et all keep talking about.
Looks like Dr Duffy has quickly updated his linkedin profile, now citing his new position and confirming he was employed at Merck upto the end of September. So to all the shorts saying he was let go, bs is being called.
Experience
Northwest Biotherapeutics
Vice President, Medical Affairs and External Collaborations
Company NameNorthwest Biotherapeutics
Dates EmployedSep 2019 – Present
Employment Duration1 mo
LocationWeston, FL
Merck
Company NameMerck
Total Duration5 yrs 9 mos
TitleResearch Scientific Director
Dates EmployedMay 2018 – Sep 2019
Employment Duration1 yr 5 mos
LocationWeston, FL
I have had a feeling for a while now that a big player has been in the background pulling the strings. I would not bet against a partnership announcement with Merck after topline announcement.
No need to worry JR, every one of your posts is Comedy Central. I am sure that your hilarity will be increasing over the coming days and months. Looking forward to your comedic hit pieces because let’s face it the stuff you spew has to be a joke right.
Agree GGB, if topline reveals stellar results and 60 to 80 people still alive I cannot see anyone bar day traders selling at 1 to 2 bucks. It would be akin to giving strangers to the stock who have just got interested due to sudden spike a gold coin for the price of a copper. Basically you would be giving away your families wealth to complete strangers for nothing. Who in their right mind would allow a stranger to walk away with all your hard earned winnings after years of suffering through countless ups and downs.
I remember Biosect stating that the next game played by the shorts would be trying to convince longs that a good price would be 1 to 2 dollars.
For me this is what I call a gold bar stock and when the results are revealed and the true value of this company starts to sink in to the general public only then will we see the demand and value reach a point where a few may start to release a small percentage to an increasingly desperate set of new investors.
The ride will be wild and timing the crests critical.
I look forward to the coming months and for this companies strategy to be finally revealed. Only then will I make a decision as to how and when I will distribute my gold coins because let’s face it longs will finally be in control and any shorts out there will be begging.
I occasionally peruse the board to see what mud is being thrown at NWBO and find it amusing that much of the conversation has centered around the SAP.
Let's be clear about the SAP process during a trial and in this case a blinded trial.
1) Statistical analysis plan for a clinical study – describes the planned statistical analysis of a study
2) Interim statistical analysis plan – describes the planned statistical analysis of an interim analysis for a study and therefore needs to address handling of partial unblinding issues in case of blinded studies. It also describes possible impact on the conduct and the complete final analysis like the possible adjustment of significance levels.
3) Data Monitoring Committee (DMC) statistical analysis plan – modification of interim analysis used for DMCs and describes regular (e.g. monthly) data monitoring procedures for safety or efficacy questions. The DMC SAP also contains the DMC charter which clarifies exactly the names and responsibilities of the involved parties.
4) Integrated statistical analysis plan – describes the planned analysis for an integrated analysis which is used for example in submissions. It defines the details of programming output for an ISS and ISE usually in one document.
So NWBO is in the process of submitting their final Integrated Statistical Analysis Plan that no doubt has taken longer than expected considering they have employed the services of 3 world renowned statisticians. The confidence I gain is that they have these renowned statisticians in their employ working closely with the experts to produce a finalized SAP that will pave the way not only for this trial but for all future DCVAX trials.
I believe that once they have DCVAX-L approved under the new SAP protocol they will have a powerful new weapon under their belt that will bring worldwide attention to their pipeline. If BP is not taking this little company seriously at this point believe me this will end once we reach topline under the new Integrated SAP guidelines.
Here is an example of an SAP being changed multiple times by Bayer so yes this is common and an expected part of final SAP submission by a company especially those involved in a blinded trial.
[url][/url][tag]https://clinicaltrials.gov/ProvidedDocs/24/NCT01776424/SAP_001.pdf[/tag]
Clearly you at least give some credence to the extent of work that will be required to create an SAP that no doubt will be pivotal in any future trials NWBO will submit to the authorities.
At the ASM LP clearly stated the ginormous task that is required to map out a brand new path forward for analyzing data from such trials.
This is no small task and it looks like they only started work in January once they had acquired the expertize to work on this.
From the meeting.
We have worked for the past 5 months with 3 world class,
independent statisticians to develop a draft SAP using state of
the art statistical methods
– This stage required the most extensive work by the Company and its
advisors
• The draft SAP is nearly complete at this point
So in Summary they are 5 months in and I believe they will have at least submitted the preliminary draft within the coming weeks.
Now considering the length of time and effort they have given to this SAP I am also confident that the regulatory bodies will have very little to counter their proposal.
We shall see and as they say Stay Tuned.