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5/3/2011, 6,000sh at $0.48 was my first NWBO purchase. Been a LONG time coming, and I felt like I burned so many people convincing them to invest. Since then, I have bought over $10 and under $0.18 (after the rSplit). Got CREAMED on 5/10/22, but bought back in strong. 50K more today at $1.03. Been reading this board forever...
I feel like this is it, but I have said that before! Time to plan the exit strategy. When to get the basis out, when to sell half of what is left, and then sit back and watch. All those nerves are firing again. LFG!!!!!!!
Wow, after 11 years I finally get the news I thought I would get, and the share price does what I would have expected with failed results. Feeling pretty dumb.
Can't believe I sold off 25% in the .90's. I would love to have those 50K shares back right now, but I promised myself if I ever got out of this 9-year hole I would pocket some risk.
I think I have checked my phone for a stock quote at least 50 times today! Going to be an anxious weekend...
OMG, after all these years I am finally back to my ave price of $0.72. Lots of mental anguish with that. 150K invested (a lot for me personally). I am thinking to pull some off if we hit $1 and de-risk this, but I want to ride out what I put so many friends int, although they all bailed out for a loss. Have to keep my wits up and emotions at bay.
May 2011, invested way too much to get ave down to $0.72. Adrenaline kicking in, have to play this right from here on...
Could this possibly be it?!? Actually going to data lock for real this time? Been in since 2011, put so many people in and buried my head in the sand after that. Tired of carrying this weight, shoot the guns off!!
You must be west coast, because I am on the tail end of BBQ and beer! I'm just saying that with GBM or other specific cancers, there is at least a consensus or some empirical evidence of data that can be presented in a table or graph. That does not exist here, so I cannot tell if 12 months of survival is remarkable, average or on track etc. etc.
What is the OS expectation for SOC with these patients - in months? If you do not know, then there is no SOC survival expectation, right?
But that is just the point, there is no SOC for these patients. They are at the point of no more treatment, and (I believe) each individual is given a life expectancy based on their own doctor's opinion. I do not recall there ever being a metric for SOC, especially when there are multiple cancer types in the trial.
I knew this treatment would be significant. I wish there were some comparative of survival, but I have seriously high hopes for the DCVax Direct treatment. Bosch is a hero for this company, I knew it when I met him - no offense to Linda. There cannot be any real conclusions without a placebo, however, which is why we have no idea how long the patients should survive. When I see that survival rate is very good, I still do not know what it would have been without any treatment. This was not mentioned, because they likely do not know either. My feeling is that the treatment is a large advancement, and I think we will see the market agree in the near future... I may be jumping to conclusions, but I liked what I heard today.
Let's think logically about when data can be presented for DIRECT. FINAL data, as was written by someone, shouldn't exist until at least July/August 2016.
Clinical trial site:
Secondary outcome: Number of patients with tumor response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Other outcomes: Number of patients surviving [ Time Frame: 24 months ] [ Designated as safety issue: No ]
•Number of patients surviving without tumor progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
I don't expect to see a waterfall chart on OS like we saw in the 51 patient data until half of the patients have deceased or 24 months from the last patient treated. If they were to present OS data now, how would we interpret it? Since there is no SOC in this trial, the 24 months is the only guideline indicating what a positive OS might be. Could someone on the board tell me what a successful OS might be? What would the expected OS be in a placebo arm? Since I don't know that answer, I am not sure if there is meaning to survival rates on patients at 10 - 12 months, and OS is what I am most interested in.
As far as tumor response goes, I do not know how they will define this. If it is the recist criteria, then they will likely present any remarkable data (large % with CR or PR) as soon as they have it - or at 18 months from the last patient treated. If they could report 50% PR+CR to this point, I think they would. Unless they see something very positive, it could take until 2016 to see a complete data set, and who knows what it might show. Of course, I am hoping they have something great to present asap.
On a sadder note, that was a painful presentation to watch. I feel bad for Les, as he did not seem prepared. I would think he could describe what the L vaccine is more effectively than he did today. Gotta Go...
NWBO 4yrs LONG now.
Flip (or whomever knows), speaking of case studies and anecdotal evidence on Direct, do you think that is all we will get until end points are reached. More specifically, the 18-month PFS endpoint and 24-mo OS endpoint. For a complete data set, should I assume that means the 18-month clock starts the day the last patient received their first treatment? That would place the final data collections around Jan 2016 and Aug 2016...?
From Evaluate:
RRRichmond, I think this point is something of great future interest. After a presentation on Direct, Bosch was asked how long the patient should continue to receive the vaccine. His answer was not 32 weeks, but rather, until there is no product left to administer. Logically, I don't think it would even end there. Continue to manufacture DCVax-X for... life?
As far as all the discussion on the stock price goes, I am not at all surprised by the drop. The day they announced the trial expansion (i.e. a delay to results), I knew we were headed down. Scientific communities do not determine the price. If you remember Dendreon, the recommendation shot the price way up, then the approvable letter delayed action for a year. I think PPS went from 4 to 20 and back to 6 or less. Ramp up is coming, particularly at 1st interim or announcement of full enrollment. Wall St has never felt to me like a long-term investor, they seem to look for NOW. Nothing can tell us for sure that there won't be more delays, but we sure know there will be multiple cash raises and dilutions before the hammer drops. NWBO is on the radar, but our maturation is just not happening until Decision-day gets really close. Direct has been a potential game changer, but imagine if this trial was never initiated. The length of the L trial would be crushing us.
Flip - thank you for the meta-analysis read. Great reassurance of what we all believe in, and I stared at the data tables for quite a while.
NWBO tweeted this article, and I am curious about this line in it:
No LP at ImVac yesterday, it was Bosch. We talked for a short while and I listened to his presentation. Much different than anything LP gives, as this audience of about 25 peer scientists were very technical and advanced. It was only about 25 minutes long, and the first half was methodology of proving that the immune response was present. Basically done by detecting immune responses like TNF, IL-6 and IL-8 within the injected tumors and clear activation of CD4 and CD8 with evidence from staining.
The second half was dedicated to case studies from the direct trial, most of which we already know and none with biopsy reports from week 16 yet. Very quick summation of the 4 case studies:
1 - Melanoma, wk 8 biopsy. Granulomas and T-cell infiltration at the site, no tumor cells detected in the lesion or the lymph nodes (lymph nodes, however, were not checked pre-treatment)
2 - mCRC (metastatic Colorectal), wk 8. Granulomas, no tumor cells detected in biopsy. Tumor has increased in size, but patient boasted of how great he was feeling and wouldn't think of discontinuing treatment. He/she is nearing wk-16 injection
3 - mCRC, day 7. Extremely active T-cells. May have had CD8 cells already present, must look at prior treatment. All of these patients have had multiple treatments in wide varieties.
4 - Sarcoma, wk 16. Moderate immune response, large necrosis. T-cell receptor sequencing revealed significant increase in T-cells from day 7 to week 8, 16 (wk 8 and 16 were close to even amounts). This suggests a systemic response. I believe this is new information.
There wasn't enough time to discuss everything the regulars here ask about, but we touched on a few things. For example...
The main reason for the changes to the trial were based on findings in the scientific community on MGMT Methylation and the depression of WBC in a large portion of the trial. Since the PFS and OS in that group are predictably lower, the design has to also see them as a subgroup. I personally think this means the total events has to increase in order to reach enough events for statistical relevancy in the non-depressed group. If it is known with high certainty that this group exists, it will be too late to account for it after the results are in. If they did in fact drag the numbers down, and the FDA could ask for another trial to prove it. Best to account for it now.
The new interim analyses for the trial are at 60% and 80% as usual (149 and 198 events). I suspect that if the subgroup was only slightly affected to the point where their PFS and OS are still improved >6 months, the overall group results at 149 events will be powered enough for efficacy halt.
Enrollment estimates and trial length are based somewhat on the European sites all becoming active. They are higher volume hospitals (on average) and enroll at much faster rates than most of the US sites. Hoping for new trial sites soon.
Wish I could stick around and blog about it all day, but gotta work. BTW - Marnix Bosch, really like that guy.
Bio -
That was kind of the sentiment I had as well, but timelines aren't really NWBO's thing. I may be reading too much into the fine print here, but I wonder what this means exactly...
Dok - not fretting or making anything up, just asking a question.
I watched it again, and LP discusses the HE and Reimbursement in detail but without mention of timelines. I will take your word for it on the six months, which was what I was looking for, because I can't seem to find anything via on-line searches mentioning that amount of time. I believe it will be the next important PR, so just trying to figure out when it may be coming. Thanks for the response.
Does anyone know the actual laws on reimbursement in Germany? I feel like we should have an update on pricing and coverage by now - four months and counting. Or, am I waiting for something that will never be announced? This could have a major impact on the need to dilute the shares again and again.
I remember someone posting some sort of deadline where a third party in Germany decides what the full price will be. I can't seem to find that on-line anywhere...?
Here are your answers...
1 patient treated? NO, When? Not yet, Several? No, Self-paid? None yet, How much? None yet, Any progress yet on reimbursement negotiations? Yes, Getting close? Progressing on track, waiting on Germany
I think the pool started after the May 15th PR (anyway, I lost because I said 1).
I do think the Direct (D) results will be their main focus, along with boasting previously reported news on German exemption to those who are unaware. IMO, the D results are GOOD. Not great or worthy of the rooftops, but good for sure. The tell me that immune therapy does have an effect and likely will be a component of SOC in the future. I am still a little skeptical about whether or not the effects will improve or not with time. They said the first patients were treated last summer, so I would like to know the most recent data on those individuals. That's why I was wondering if anyone is attending ASCO and may be able to get case study information on the patients that have been in the program for the longest time?
If you're just looking for another guesstimate by LP (which seem to cause more problems than they solve), then it's probably like that link to The Money Pit someone posted... 2 weeks!
I must agree that we will not hear anything about L. I don't see why many here are so demanding of answers and updates on the L trial. I truly believe there is nothing to say!
Q. How far along are you on enrollment?
A: We are not at liberty to say as it could jeopardize the trial (LP has said this before).
Q. What will pricing be in Germany and do you know if the HE will be reimbursed?
A: As soon as we have the answer to that we are legally obligated to share it, so we don't know.
Q: Is there a DMC efficacy decision still pending and what is the reason for the delay?
A: We have not received any DMC recommendation on efficacy. (if there is a known reason for delay, I'm sure they cannot discuss it, especially if it can affect German regulatory decisions).
Q: When do you expect the 88th event?
A: I haven't consulted the crystal ball yet, but I'm sure it knows.
Q. Are you expecting some sort of HE equivalent in the UK?
A. We have applied for it, but we do not have the answer yet?
Q. Are you planning to expand the trial?
A. That option is available, but there is no decision to do so at this time.
What are the other questions?
If you want to ask about the unlabeled, 99 patient trial, they may have an answer for that. I don't think that will technically be part of the L trial, as I am waiting to hear what that's all about as well. That may be an announcement coming.
BTW - if you count the rebuttal and conference call, we are up to 3 PR's. If not, we are still at 1...
Pyrr:
"Most of those 19 patients with available data are only some 3-6 months into treatment. Given the crescendo ability of immunotherapies, we will likely see a much greater response rate (tumor shrinkage, among other things) the closer to 18 months out for each patient we get. As well as confounded RECIST due to inflammation subsiding."
I truly hope that is the case... Will anyone be attending ASCO and reading the poster/asking questions? I would like to know about the first patients treated of the 11 and see if they experienced ongoing tumor shrinkage or if it flat-lined.
If you are going to write a complaint, I think you would need some quotes that are false and an explanation of how they are factually false. I believe misleading is allowable, but if you can prove false you can make a case.
Evaluate, I think you hit the nail on the head there. Most likely, the DMC is either holding their efficacy recommendation or collaborating with Europe on how to proceed, as the German decision is somewhat unchartered waters. I don't believe we will hear any efficacy reports until Germany has pricing and reimbursement plans outlined. Unfortunately, Germany is slower than molasses, and the PPS seems to slide a few % each day. Now we are relying on the PH 1 trial to boost the PPS... sigh.
True, I forgot about the embargo reason, but I think they had some data on the first subset even before they submitted an abstract for acceptance. If they had seen many instances of tumor regression and necrosis like that which was just reported in the case study (prior to their abstract submission), I think they would have shouted it. Still, it makes more sense to wait for the second set of data to report anything at all, but I think they want to have some data for ASCO and the public. Does that mean I have no appreciation for how difficult it is to treat lung cancer?
I like the prediction game, even though nobody won last time bc we still have yet to see any DMC efficacy recommendation. I will predict 1 PR, probably at the end of next week.
My logic: NW has had the 8-week data on the low-dose cohort for a while now, but it was not impressive. If it were, they would have announced it before their offering. The middle-dose subjects have only a few data points past the 8-week mark (we read about one), but two or more data points may be collected by next week. Maybe that gives a total of 8 or more to report on, and even NW is on the edge of their seat hoping for highlights.
For exemptions and news from Germany, I think they would have to report this news when it is available (or as soon as they can translate it into English), so I doubt we will hear anything about that. I believe they forced their own hand by prematurely stamping this huge presence at ASCO, mainly because LP is very bad at timeline estimates. They will not have most of the goals met from their estimates, such as full enrollment in L and full enrollment in D with substantial data. I would love to see the PR campaign begin, but I just don't think they have enough to say yet...
Speaking of full enrollment in L, shouldn't that be coming up soon along with the 88th event? Patience, patience... patients!
I hope bbking's big announcement is in regards to German pricing and reimbursement from their health care system. That would lift a huge weight of projected future fund raisings and dilutions...
Pyrr,
Welcome as the new moderator. Personally, I like to see stickies which have links to highly pertinent information, not just for myself but for newcomers (only a few though). I've read every post on this board for over 3 years, and it I used to hope for more traffic. Now it's impossible to keep up with the reading, much less find a post that had a link. Anyway, do whatever, it is fine with me.
For market cap, I have always been bothered by the fact that Celldex CLDX has a 2.9B cap (fluctuates obviously) and they are well behind in the process to NWBO, sitting at 350M. I do not fully dilute in this comparison, because I have not checked what the fully diluted CLDX shares would be. I attributed much of the discrepancy to the balance sheet, as they are better funded, but with this new 'income' about to be generated I don't see why they should have a higher valuation. They work with monoclonals, which carries a higher confidence based on historical drugs, but I think we are looking at a change in perception. NWBO should exceed 1B quickly and a steady stream of press could push it to 2B (where it belongs at this point IMO).
I remember Linda saying last year that if the Direct trials were successful they would be "shouting it from the rooftops". Well, 4,000 ft2 at ASCO is the top of the roof!
For the office pool, you can take my bet of next Tuesday, March 4th. I will be away at a conference with little time to read and/or react, so Murphy's law tells me that's when things go haywire. I predict a 'continue' and a price decrease to 5.50 (load up again?).
Also, for my own hypotheticals, I made an 'events' spreadsheet I wish I could post here in an attachment. It is based on averages of 7-month events for placebos and 15-month events for DCVax (a little cushion for 6-mo extension). Entering my own conservative guesses for enrollment each quarter and full enrollment reached by October, it spits out that 66 events would have taken place around last August (one full quarter ahead of what they saw) and Nov would have been around 80 events. That's enough wiggle room to account for longer SOC PFS and maybe more survival cases with zero progression (which highly enhances approval probability). This re-enforces my belief that approval is coming, but the estimates are not so lopsided that they will halt at 1st interim (hope I'm wrong). 88 events could follow about 6 months later, so second analysis is not that far off. Anyone know how to post an attachment so Flipper can dissect, reject, chew up and spit out my spreadsheet?
I like that they are planning a large presence rather than blending in with all the small booths. It makes an impression that small companies normally cannot make. The problem I see is that they don't have enough to present (or do they?) to warrant this position. These conferences are booked up to a year in advance. At some of them, you sign of for the following year the day you leave. I think when they signed up for all this space they believed all of the following would be true:
-- Full enrollment in DCVax-L Trial
-- German sites actively recruiting for over 6 months
-- A dozen or more patient results from Direct trial
-- Partnership for Prostate trial
It would be a little disappointing if none of these are true when ASCO is in session. I too think this is a year pre-mature, but this is their big conference for the year. I still think the money spent on the conference will be well worth it if there is a trial stoppage this year. On the other hand, there is a good possibility all of these topics above will be their same discussion points going into ASCO 2015. I wish I could attend, and I hope someone on this board may be there to do some reporting work...
OK, so I kind of contradicted myself. My thinking was more to say that they do not have any sort of data set yet. One data point (datum) does not constitute "data". If they have 2 data points it may technically be 'data', but really I am referring to a body of evidence as the word is typically used to describe. I think NWBO was expecting to have "data" by now when they announced their trial beginning last June. I believe they were referring to several data points or at least enough to see any sort of preliminary trend. We are just talking semantics now, but I think you understand what I meant.
My 2 cents:
As I said in recent posts, they just don't have data yet for direct. My fat gut tells me that their first patient probably cycled from August to October (8 weeks?) at the lowest dose before the second patient could receive treatment at the medium dose. They probably cycled from October to Dec/Jan at the middle dose. Now a third patient at the high dose is probably not even at the 8-week mark yet. When she says they are encouraged, my guess is that the first patient responded and the second patient experienced tumor reduction. What I'm curious about is whether or not they have the green light to continue with the low doses now that time has passed. She has expressed previously that the enrollment should be rapid once all systems are go.
I also feel that Linda is pretty green in this Biotech space. She is continuously wrong about timelines (going back to when she thought enrollment would be completed by Jan of 2013 in one of her webcasts). She went on to explain how they did not anticipate how long the screening processes took and how expensive they were. Then she says enrollment completion expected around June 2014, but we know that has no chance. She was also unaware of the 'slow' period of an orphan drug trial. In this latest webcast she is trying to tell everyone what a long process it is to start trials and prepare for manufacturing in Europe as if she has been enlightened with information nobody else understands. It positions herself as someone who is learning as she goes. I don't mean to be critical or to fault her, I am just saying the large pharma often hire new CEO's with this experience when they hit the transition from proof of concept to commercialization.
I think Linda is grinding and she IS someone we want behind the wheel, with all the company's (and her own) best interests in mind. I think she knows they have a winner here, but I wish she would stop saying 'chances to win' as if this were a game show. How about 'opportunities to succeed'? My point is simply this: the DCVax-Lysate platform is destined for approval (maybe the Direct platform as well), but the timeline could be anywhere from 6 months to 5 years. That's why I think this is a LONG position and the options are just too risky.
Direct results are probably held back because they don't have any. As the blog said, only 3 people had received treatment as of Jan 27. Not that a blog is gospel, but I believe it. Linda said the FDA would not let them treat more than 1 until it came back safe at the lowest dose, then another, etc. (paraphrasing). My belief is they only have data for 1 patient that goes beyond the 16-week mark. Second is probably close behind, and a much larger number that have just started. Just my gut feeling...
Bio - just curious, but why are you using the phrase "expired"? There is no type of date set by the DMC that I can find. The PR said "it is anticipated that the DMC may complete its evaluation and recommendation approximately six to eight weeks from now". As we have seen from NWBO in the past, they have no idea how to estimate timelines for anything, so I am wondering if you have some information that validates some sort of expiration date for analysis. Thanks.
Always watching, and eyes will be peeled next week. If the groundhog sees his shadow with a mere FDA 'continue', which in turn causes a dip, then I may just have to add more shares as I wait out the long winter...
I totally agree with Shanak. This board is a valuable source of information and links, and it has been (for the most part) only meaningful posts. They have become more frequent and repetitive lately, but at least on topic. It would be a huge disappointment to see personal conversations or bickering about trivial things. I can't even log into yahoo anymore, because it is not worth my time to hunt for something worth reading.
Anyway, about NWBO. I am fully prepared for a presentation that may (at best) give some enrollment estimates for Direct, but no data. From reading the blog link (posted by Flipper I believe), a potential patient stated on Jan 17th that only 3 people had received the treatment so far. I am not too surprised to hear this based on Linda Powers' statement about people lining up to participate, but the FDA pushing on the brakes because of safety dosing for an orphan 'drug'. Now that they are through the safety portion, I think enrollment will be rapid, and the need for increased capacity could be partially driven by the estimation of DCVax Direct trial needs (through Ph III we hope).
For the GBM trial, the link to the FDA site had a review date of Jan 31, which I believe will be the interim analysis date or close enough to it. I am also prepared for the ruling to be simply to continue the trial. This week has the potential to be huge with data and FDA rulings, but realistically I would say it will end with the same outcome = "keep waiting". But, anyone that is still waiting to get in better hurry, IMO.
My reaction to the press release was mixed. At first I said, Powers' is siphoning money out of the shareholders with an extremely deep position. Then, on the other hand, she must be the biggest believer there is, and this move will probably prove to be extremely beneficial for the company. It is a situation other start-ups cannot take advantage of. I'm sure the dilutions are not over.
Looking forward to any information that can be shared about today's talk.
Just read the previous posts. If the 2006 number was 33 instead of 50, then that's my mistake. Either way, you see the point I'm making.