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I kept asking myself the same question. Why dilution to keep the company open for just two weeks vs one or two months? In less something is about to happen in those two weeks.
The only part that I disagree with you is that the 233th event has not happened yet. I think it happened in July or August. But whether or not it has happened will not make that much of a difference since the remainder 232 events have happened already. If your right about NWBO going another 3 to 6 months for the remaining survivors than Linda is playing with fire finically because there is no guarantee that the publication will make the stock move up much in less there is really strong evidence that the trial was a success. Right now it feels like top line results will be the only thing that will move this stock up a lot and at times I wonder if even that would do anything for the stock price. But I hope you are right on all accounts.
Ok, so I did get what you were saying. The researchers are basically going to give the same feeling that Bosch gave in his article. Seems unusual to do this right now before unblinding the data. When the data itself will be filled with a mountain of information for the researchers to study and mull over. The interim results would have to include the PFS. Since that end point has been reached earlier this year. Any PFS we get now for top line results will be over the 248 original number.
Kabunushi,
Just so I understand your statement. You believe the paper will be about blinded data and not gives us any new information to work with like top line results or why people are living longer in the trial. In other words no unblinding of any data.
It will be fascinating to see the difference between DCvax patients vs crossover. I do believe that the 10 percent patients that did not go to the crossover group probably passed away before being able to be given the vaccine. If that is the case than the median OS for the crossover group could go down by a few months from that alone. To be honest, I am not sure how many months the DCvax group has to beat the crossover group in median OS. I know it’s 4 months for PFS.
As for the “possible” reverse merger of Cognate and NWBO. It would be interesting situation to happen to own Cognate shares instead of NWBO. Not sure if I would prefer that over Big Pharma partnership, but it’s an interesting idea.
My finial thought with regards to top line results. I can not imagine this waiting period going on much longer. Once November comes it will be 24 months since the last 3 patients that were enrolled into the program. At this point every person that is still alive will be at least having 24-25 month survival, if not longer. Which is significant in it of itself. So no need for NWBO to keep the trial going and risking bankruptcy.
Thanks for the response
Doc Logic,
I am in the same camp as Seaking Alpha writer Boshie view that PFS will be NWBO’s saving grace in the trial since there are cross overs in the trial, OS is unpredictable. You mentioned the possibility of a reverse merger if trial results are good. Wouldn’t that destroy current investors no matter what the outcome of the trial is? Cognate is a private company and would get NWBO for peanuts. As current investors we loose are shares.
That's interesting Flipp, thanks for the response and have a good weekend also!
Flip, if NWBO can unblind PFS, but leave OS blinded, which I never knew that a company could do that in a trial. Than why has this not happened yet? The 248 events has happened already in February and who knows how many more PFS events has happened since than.
Thanks for the responses. Since they don't need to tell us the data is locked than my guess it's happening now.
"The mOS of the trial arm probably has not been established since it most likely extends beyond 22 months thus longer than the 22 months that have passed since the last patient was randomized."
Who's too say we are not at the median OS for the control group and trial arm. The last patient was randomized 22 months ago. Most of the others people are above 22 months start time. Meaning median of OS is already higher than 22 months (most likely). Also let's keep in mind that 90 percent of the people got the vaccine. It's really a single arm study of late vaccine people vs early for OS. Also I can't imagine Linda wanting to keep the trial going much longer with the finical situation that NWBO is in.
Years keep going by and so does the NWBO phase 3 trial. It's nice to see familiar faces on the board still (Flipper, Cherrytree, Xena and others I missed.) I hope everyone here is doing well. For anyone curios, I have not sold my NWBO shares and have not added either. Just waiting on NWBO trial results and working on other biotech stocks.
A few questions i have: Does NWBO need to make a press release to the public when they decide to finally do a data lock? Also with both requirements OS 233 and PFS 248 being reached. Wouldn't the median OS already be figured out from the entire group of 331? So there really is no need for the company to let the trial go on further than the 233 OS events. Right or am I missing something here?
I agree, most likely those catalysts will come sooner rather than later. As far as the whole debate on this board about Cognate I think it is pointless. Cognate and NWBO got this far together. At this point Cognate has no real involvement with NWBO until screen halt is lifted.
Very true
I think the $8.00 a share dilution could of happened when we were at $10 a share range also.
The stock got in the $12 range. I am sure they could have done a $8 a share for $100 million. Which would be 12.5 to 15 million shares diluted. Yes it would have sucked at that movement, but when the goal is to finish the main trial and you get that chance to secure your future financially, you take it. Especially as much as NWBO has been attacked by AF and hedge-funds.
Right now Cognate is not even important. Enrollment is at a halt and every patient in the trial have already had their vaccine made. Larry Smith's said it best. NWBO is fighting for it's survival financially. Hopefully the screen halt will end soon and investors gain confidence to buy more shares. 10 months and counting on screen halt. The part I disagree with Larry is hedge funds and shorts alone did not cause this stock crisis. Multiple times between $9 to $12 NWBO could have raised enough money to help the company cross the finish line with the phase 3 trial. But they didn't so here we are.
Thank you. for your thoughts. I will trust Dr. L and Dr. B's belief also. As for Pry he just thinks he's right 99 percent of the time. When he is wrong he thinks it's a miracle lol
Exactly, I think people might be too focused on the screen halt vs how many are probably enrolled. Reaching a PFS of 6 month improvement should be no problem for DcVax L. Especially if the screen halt was do to a manufacturing delay or hospital reimbursement in Germany. I strong suspect the delay was do to Germany since the last patients to be enrolled is from that country.
If enrollment number is not as important. It seems to me that the trial will end one way or another. Either by whatever caused the screen halt or 248 events happening with what enrollment NWBO has now.
"That was my guess from the beginning as to why the screening stopped where it did. That would require sponsor involvement, however... but maybe indirect involvement. Maybe NWBO and the PEI negotiated when the look would occur to evaluate HE reimbursement, and NWBO pushed for the point where 312 were enrolled, matching the required enrollment to reach SS for 6 months PFS advantage, the old bar, as you said."
So if we are correct about enrollment being close to 312. If NWBO reaches 248 events soon. Does the trial stop and NWBO does not need to finish enrollment, but the trial itself is complete.
Great Question! Can a trial finish if it hasn't even fully enrolled?
I love the question you brought up because this is a huge reason why I invested in NWBO recently after being gone for so long. Although I am a young investor to my understanding of this trial that it will end at 248 events no matter what and having complete enrollment is not as important. We know that there are over 300 patients enrolled. We know before the trial resized that it use be 312 patients to complete enrollment. It is very possible that NWBO has about 312 or more patients currently enrolled. If NWBO reached 248 events some time this year. Wouldn't NWBO just need the PFS and OS to be greater than the amount given before the resize in trial happened?
Thank you Flipper and Kabunushi for explaining the science and manufacturing differences between the two companies. I did not know Argos existed until today. Makes me feel more comfortable knowing that Argos has stopped focusing on fully automating their systems. I think your right Flipper that chemotherapy would affect the development of fully matured T Cells.
Flipper,
I am sure you have talked about this already on this board, but I would like to know your thoughts. I know Celldex, IMUC and Agenus all too well and their products. What is your thought on Argos RCC vs NWBO DcVax L in dendritic cell therapy? In terms of manufacturing and effectiveness. I ask this because if both get approved this year or next they will probably compete with each other in off label use in other cancers.
Two PR's in the last two months on updating what the company is up to. Both having nothing to do with share dilution to raise money. Seems like a good omen to me :)
Everything DoGood said is true. Rarely does the market understands how well or bad a company is truly doing. It's why I waited to buy my shares at an average of 82 cents a share because nothing scares investors more than silence from a company. I do feel the market has over reacted with NWBO. This company's phase 3 trial is not much riskier than it was last summer when the stock was trading in the 12 dollar range before the screen halt. Plus I am not a bad person for taking shares from investors who sold because their stock price went down from when they bought in at $6 a share or higher. I am just a savvy investor. NWBO is so close to the finish line it is stupid to sell at a huge loss before results come out.
I agree, different sites are not updated regularly and that's on top of Linda keeping her cards close to her chest. So it's hard to know whats accurate anymore.
On column B where it says "suspended by sponsor" it's left blank instead of yes. That's why I got the impression NWBO did not cause the screen halt. Of course it's blank and without a no in it. So who knows.
If this document is accurate than the sponsor did not cause the delay and we can rule out NWBO trying to increase trial size again.
Also how do we know the screen halt is not from a government agency outside the US like Germany, Canada or England?
Ok, thank you. If you do find it for Canada, please let me know. Thanks again, I think you maybe right about this being the reason for the screen halt. Makes the most sense to me compared to all the other theories out there. :)
Rkmatters, Does NWBO have patent for the new manufacturing process for Canada? You mention America, England and just now Germany, but said nothing about Canada. If no patent for Canada would this possibly delay the L trial longer. Thank you for your DD toward this board. Much appreciated.
It's nice to hear Allen is doing well. It's a good reminder that the company has a good product. We may not agree on management tactics probably because I see this is from a purely investor point of view vs you who is seeing the product at work first hand, but if they can get L and/or Direct to the market than we will both be happy. At the end of the day you and I are allies because we own part of the company. Good luck :)
"I mean why spend the money if you have nothing to say, or does appearances matter to them? You tell me."
Hopefully they do have something to say at ASCO, but your right. NWBO should be watching every penny while this screen halt is active. There is always next year with ASCO assuming things goes well in the phase 3 trial.
DoGood DoWell, I have watched this company since 2012 and I watch this company attacked by the bear writers like AF over and over. The share price today is not from just bear attacks but managements silence. My biggest problem with management is until recent with "operations update." The last time the public has been updated by the company is August of last year announcing the screen halt. Making 9 months of silence from management. UCLA professors with youtube videos have given us more feedback than NWBO. The reason the share price has been deflated so much, is because investors are only hearing from the bears right now. A good management team would give updates and motivate investors spirits to stick with the company. Also the management knew they were talking to the FDA about the screen halt in August. If they were going to take this tactic of silence and playing their cards close to the chest. Than they should have made a big enough public offering to pay for the rest of L trial while they wait on the FDA. Everyone knows FDA takes about a year to get back to a company. That said, I want to say thank you DoGood for lettings us on yahoo message board know about Allen in the Direct trial before his video became public on TV. I hope he is still doing well.
I believe in the science of the company, but not the management. The trial could go either way. Success from a good drug or failure from a poor trial design. My risk is a lot less than what it was when I first join NWBO. Something unusual is happening to the phase 3 trial. My guess is the data the FDA is looking at is "why a long survival rate for the entire population of the trial" like the UCLA Linda suggested. With good results from L trial and partnership trials with Merk and Bristol. The stock could easily fly up. Now I am playing with a 1/3 of profits from what I made from NWBO last summer. So I am going to see where this phase 3 trial goes. I am averaging 82 cents a share and this is money that I can loose. So like you, I am ready to ride or die on this investment. :)
I caused that gap up from this morning. I won big time from NWBO last summer and left before the crash. In fear of not hearing full enrollment in late July. Now that 9 months have passed since the screen halt I decided to buy 100K shares at these low prices this morning. I have been patiently watching the company dilute the price and fall while the trial continues. I believe the final conclusion too the L trial is drawing near. All 300 plus patients have had at least 9 months or more in the trial. I do not want to miss out on the final results of the trial.
Bought 100 K, around 10:20 am you can see the spike in the chart, I have been out of NWBO since last summer with a $250K profit and waited to till now to return. I am staying to see the conclusion of the L trial. I think judgement day is coming for this company. Nothing that the company did right or wrong will matter soon. Only how the L trial ends. Good luck to all my fellow longs.
Afford and Vator
I am on my 3rd post for the day, so I will wait till tomorrow to respond more.
Afford: I was talking about today and yesterday. NWBO is up 25 percent from the $2 price. So it is doing good right now from the market being up. Obviously from a bigger perspective the stock getting smacked around from the lack of transparency from screen halt in L trial. But I left last summer a $10.27 from not hearing about L trial enrollment. Right now I am looking for a reentry point for the NWBO stock. That is what I was talking about with Doc.
Vator: I could only wish that I could get in at 30 cents a share with NWBO lol. But I am 28 years old and have only been a stock trader for 3.5 years. I rode through the last big drop with NWBO from IMUC failing their trial and sold last summer near it's high. But if NWBO hits 30 cents now it will most likely be because L trial failed than I would not get back in.
Thank you Doc for showing the difference between Engineered T Cells from the Blood Cancer trial and NWBO Educated DC therapy of NWBO. Also I do remember you saying NWBO probably is at the bottom of the price at $2. As mush as I would love to find the bottom and get in. I am glad to see NWBO doing well. The company has been good for me as an investor. Glad to see it is up to $2.50. But I am going to stay on the sidelines for now. Even if it means I miss out on a good gain. There is still no news on the L screen halt and when/if it finishes enrollment. Also at some point this summer NWBO will need to raise more money. For now it looks like the stock is up because the market is up right now. If the trial gets back to finishing enrollment with no explanation and a big dilution raise happens. Than I think I will find a good entry point with the stock again. Good Luck Doc and nice hearing from you again :)