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When a trial gets to it's primary endpoint how long does it take in general for them to PR some information?
I don't want to start whining again like I can do, but I do hope you are right. I just really want some clarity and believe we as shareholders deserve it. I just don't have the patience some others on this board appear to have.
Flipper, I am myself finding it hard to believe they could just brush by the 248 events. I don't really know how they could do that legally or at least without getting themselves into major trouble down the road if OS failed. If I am missing something I would love to know. Would appreciate your opinion on this. They have to say something about the condition of the "L" trial pretty soon as well, don't you think? That is if they are not pretty near 248 PFS.
I am going to respond with a non scientific answer just my opinion from what I know about cancer. I think the crossover arm could do very well maybe even better when measuring time after recurrence than even the treatment arm since there has not been any exposure to the vaccine and selection of cells that can evade the immune system yet. In the treatment arm, this has already happened. This could make analyzing results more confusing. I would like to think though in a good way. In the future those that recur on "L" may benefit from another biopsy and a new round of "L". With or without re-resection. Still so much to figure out as you can see. I am starting to confuse myself now:)
I can accept that argument.
I actually got the number from someone who had a talk with their representative at the conference. So I trusted it.
There is point that I wanted to make about the phase 3 trial design and why PFS was chosen as the primary endpoint. Dendritic cell trials, when this trial started enrolling, were very hard to get patients into. So the reason they created the crossover arm was to get patients to enter and stay in the trial. Once you have patients crossing over after eventing, OS cannot be the primary endpoint anymore. You are then left with PFS as the primary endpoint and OS as the secondary endpoint. This being said what really matters is the end is OS. We all know by now patients are living longer. It really is that simple as to why PFS is the primary endpoint. An example right now of how difficult it is to enroll patients in trials like this is IMUC. They started their phase 3 trial several months ago I believe. As of the conference in England a few days ago they had a grand total of 6 patients enrolled. My guess is we will not see the end of that trial for another 5 years.
Even if the DCVax L phase 3 trial is not fully enrolled, it is pretty damn close. Let's say 325 patients. Les has indicated that it is higher but that does not matter. They need 248 PFS events and 233 OS events and the trial is over. It does not matter if they enroll any more. The patients enrolled are still being treated. A few patients will not change the P value much at all. In this scenario if they do not enroll a few more patients it does not make it easier for them to pass the trial with a significant P value, it makes it harder. So if they do have a significant P value that is even a stronger case to the FDA for approval. The way that it sounds from UCLA and the company that is the case. The fact that it is basically October and we have not heard anything from the company makes the chance of failure pretty slim. So any investor on Wall Street who is not putting a little money into this company because of the halt, really in my opinion does not have a clue. If I had the funds that some of these people have I would take a major bet on NWBO. It just shows you how ridiculous Wall Street can be. The sad thing for retail investors that have not taken some risk is once Wall Street finds out the share price will be out of control. I have no hesitation in saying that.
I believe all it will take to do that is announcement of the combination trials and a positive word on "L".
If they announce more than one big pharma deal that is huge. Name me a list of small biotech companies that have deals with multiple big pharm.'s. I can't give you a number, but it sure ain't many. And we may have 3(I have heard through another source it may be 4). If they just announce that the 'L" trial is healthy and accruing events that is enough on 'L". Wall Street will finally put 2 and 2 together. I hope it happens soon, and I think these things I mentioned will. The company cannot survive with small financings for the next 4 months. Anyone who tries to refute what I have written here that's fine. But I won't believe you:)
I really believe in the short term that the main catalyst for this stock will be combination trial announcment(s). How big a catalyst depends on how big the deal. And you could argue a clear investigation along with it.
Hey Koman, Thx for the well wishes same to you. Take a look at my post 75988. I think that answers the issue. Still trying stay strong until I am wiped out in January if things don't change:) Have a nice weekend.
TC I think we live to fight another day. The question, is this end like Rocky 1 or like Rocky II. I want to say "OH ADRIAN I DID IT!!!!!!"
Did not have time to read posts but wanted to say something about the shelf. The old shelf was to mostly register Woodford's shares. The shelf today was for registering Cognates sharesj as part of the Nasdaq agreement. Nothing really bad coming. Probably another financing at some point soon, probably small. My guess enough to get us to combo trial anouncement. Probably a few weeks out at least. I hope less though.
How could they have gone through the shelf from the end of last year. That I think was 150 million too. I would like to think some kind of big reveal?
If you could answer so I can understand. This could be a very good thing or a very bad thing. It could be great if they have such good news that there will be a demand for shares. It could be a very bad thing if there is no news and they need the shares to raise more capital in the future to keep the company afloat. Does that sound right?
I wanted to add a little more about what I said yesterday about overall survival to make my point more clear. I want posters to know that I believe that DCVax direct will work. It may work well enough in some cases as a single agent. If it does not work as a single agent, combining with a targeted therapy may get a meaningful response. I stand by my prior statement that the data presented should not be used to determine a survival benefit. Doing that is only asking the naysayers to attack. I 100% believe Alan Butler's survival is due to Direct. The problem though is in the same data 4 other pancreatic cancer patients died without impressive survival. Too easy to attack one outlier by the negative view. They could have also given more data about the RMH score used. Was the comparison group a low or high score? What was the score of the treatment patient? Were they the same? Was the comparison group low? And the treatment group high? If that was the case the data would be more compelling. The types of cancers treated were not given in enough detail. Huge survival differences in different kinds of lung cancer, sarcoma, and NET. Slide 21 can be interperated many ways. I would like to think the patients on that slide all got the better "activation" method in their treatment and the bottom 10 patients got the "inferior" activation method. Naysayers don't think that, or would not bring up that possibility. How many injections and what concentration did the long tail survivors get vs. the poorer performing patients?
So much other good information from the trial. To me, really exciting and hopeful. I think the phase 2 studies are going to be amazing to watch as information on large group of optimally treated patients is revealed. Anyways, my overall point is with the information given in the presentation I am not surprised a hit piece came out. I expected it. I wrote my original post right after the presentation but held on to it because I don't want to bash in any way something I believe in so much. To those of you who have said you have shown people in the oncology field the charts and data presented and they felt they could confidently derive a positive survival benefit, I would love to be explained why. Not just that they said so. I would be more than happy to change my opinion, in fact I would love to. Again, what I am saying does not make me believe any less we will see significant increase in survival as phase 2 results become available.
It is a poster presentation. Poster presentations are not a big deal unfortunately. The poster will be sitting in a room with as many as a 100 other posters. People who attend the conference and enter the poster hall can stop and read any poster they want. I am assuming the time that is given is when an author of the poster is standing next to it to answer questions for people who are interested. In my earlier years of practice, my chairman used to scold us if our papers were denied an oral presentation and we were only offered to have a poster presentation. Don't expect anything. Would love to be wrong, but don't think I am.
Thx for the reply:)
MY OPINION ON THE DIRECT TRIAL RESULTS
I am not happy about what I am writing but I feel I should give my opinion. I see basically all of these cancers from the Direct trial on a regular basis in my practice. Take my opinion for whatever you think it is worth. I think the data that has been given is really useless for me to draw any conclusions about survival. From a basic science standpoint there are a lot of things to like, no doubt. I have seen in my experience that the majority of time these findings do not necessarily translate to an increased survival. Granted we still don’t know what will happen with everyone getting the most active form of dendritic cell, optimal dosages, multiple tumor injections, and a full course of treatment. Makes you believe that things are promising, but that is all you can honestly say. The survival percentage is not bad. I am not saying that it is bad at all. I am just saying it is not at all that impressive. 4 of the 5 pancreatic patients died. I have had many patients with metastatic pancreatic cancer that I thought should have not lived 4 months survive for up to 2 years. I even had a patient with metastatic pancreatic cancer to the liver who is still alive over 5 years after removal of the liver metastases. It happens from time to time. The pancreatic cancer patient from the Direct study that is alive may be due to the effect of direct. He actually is in my opinion. But my patient did not get Direct, he got chemo and is alive. You also see diseases like NET(neuroendocrine tumors) of unknown origin and NET of the pancreas in this trial. Survival in NET is extremely variable. I have seen patients alive 10-15 years with metastatic disease. I have seen patients with very heavy disease alive for over 4-5 years in some cases. Pancreatic adenocarcinoma(what Alan Butler had) is a totally different animal than pancreatic neuroendocrine tumor. Tumor doubling times in tumors vary a lot from case to case and cancer type to cancer type. The same thing can be said about sarcoma. High grade sarcoma's have a wide range of survival. Depending on the type they may not metastasize and just be unresectable(they can liver a really long time) or they may have a predilection to metastasize to certain organs where survival is longer. It really depends on the which type of the 50 or so high grade sarcomas it is. Melanoma is another example. I had a patient who I have done 5 operations on over the course of 6 years(primary tumor removal, axillary lymph node dissection, adrenalectomy, and two segmental lung resections) and he is now free of disease for the past 2 years. He is now living on the East Coast to be closer to his grandkids. You would never know he was sick. I have had other melanoma patients die within as little as a few months. These are just a few of the examples I have from my eleven years of clinical practice.
Again I am not saying that DCvax Direct does not work to extend survival, it very well may. We just cannot tell anything about survival benefit from the data that has been given. Too many diseases, not enough patients, too much variability within each disease. In defense, the study was not designed to show that. I would have no doubt that if you gave me 100 patients with different cancers and metastatic disease, 20% might be alive at 2 years or at least reasonably close. I also take into account no matter how sick they were, they were still well enough to enter the trial, so they must have had decent functional status(in surgery we call it passing the "eyeball test”). Why do companies like Juno or Kite have such high market caps, and have this with phase 1 data? They had survivals that were off the charts and could not be overlooked. This even with their severe toxicity compared with DCVax “D” or “L”. 90% complete response rate is hard to ignore. I bet you if their results were not so compelling there stock prices would be in the single digits. Direct data is not there. "L" is a different story though.
I think direct has hope. I am actually optimistic that it can succeed. It should though be in no way what guides Northwest's reputation in the Market. The trial was designed to test for safety and it did that with flying colors. This treatment may be the future. Most of the companies energy in my opinion when it comes to the world of the market should revolve around "L" for glioblastoma. Success in this trial will make everything else behind it possible. I invested in this company because of "L". Everything else I have learned since is potential icing on the cake. it is exciting when thinking of the possibilities for patients and the revenue potential is staggering. I believe "L" will work, particularly well on certain phenotypical makeups. I find the survival data compelling not just hopeful in contrast to Direct at this point. “L” results are from one disease, large number treated, and survival numbers off the charts. There are more predictable historical outcomes, even more so after progression. I don't think the company is doing a good job on informing the market on "L" at all. I realize that we cannot make events happen. I am sick of that argument. Just like the lawyers or the FDA are preventing them from saying things. There are so many things the company could be open about. There is no reason that they should not be able to say the trial is fully enrolled or not. That they are just waiting on events or not. That interim analysis has been done or not. They have several years of information arm data, building of a facility in England, and a compassionate use trial(though it has on been a few years, they could say how many are enrolled). They could become clear about what is going on with EAMS. Did they pursue the second step or not? If not, that’s OK, but why? The same with hospital exemption in Germany. What is going on? If nothing is happening, why? If there is a good reason, I will accept it. I realize this stock is probably shorted like crazy, I get that. If this company used what it has and informed the public properly I believe 100% they would not be where they are.
There are so many questions unanswered, making their next move a complete mystery. Combo trials will be nice and hold significant promise in my opinion. I personally believe targeted therapy and vaccine combinations could be the new platform for treatment of most solid tumors. I think the increase in PDL-1 expression is the most important finding right now with the measurable data they have for Direct. Direct(and probably L)could theoretically triple response rates of PD check point inhibitors. Naysayers will say everyone has a combo trial with Merck or BMY. The difference is nothing is as good a fit at least on paper that I have seen as DCVax. I think it could actually end up that Aztra Zeneca’s product is the best fit since it directly inhibits the PDL-1 receptor unlike Merck’s or BMY’s products. Really could mean something for patients and help move the stock a few bucks maybe more if there is significant money up front in the short term.
I just don't see how anyone is satisfied with the information that was given, especially someone who treats these patients. I can tell you the oncologists I know, who are damn good, sure are not. The market definitely did not care and I don't blame them. I don't want to hear that I am being near sided only. I know what the potential is and I am really hopeful. There is no reason to be miserable along the way if can be avoided, which I think it can. Hopefully there is some news on “L” soon. I really would like to know where the company is. Hopefully, combination trials are also announced very soon.
My intention is not to insult the individuals who I believe are working hard for the company. I do not believe they are bad people. I just don’t agree with some of the posts today about what todays PR means. I read it as what it could mean. I think there are much more pressing things that can and should have been answered before a PR like today. Again, hopefully the hard working people at NWBO will give us some of those answers soon.
By the way, I would also like to hear where they are in the investigation. I realize there may be certain things they might not be able to say. An update though is deserved. I know they said AT LEAST 90 days. I don’t believe anyone who said that could mean 9 months. This is another example of the carrots that they love to hang in front of hour faces and never let us get close enough to take a bite. I am in this because I want it to succeed for the world and also for me and my family. I don’t have a lot of doubt it will succeed for the world in some time. For it to succeed for me an my family it has to start happening to at least a small degree soon, which is where the frustration becomes unbearable at times.
In my opinion if the stock price does go to new highs and stays up after yesterdays PR then good information has leaked and is coming soon. Yesterdays PR should not do it.
At this point would it be better to give the PR that is supposed to come just before close or pre-market tomorrow so that when the market opens tomorrow the price would gap up how ever many cents if the news is good? Saying this because if I am correct you cannot short a stock pre or post market.
Thanks for the reply, I appreciate what you do for the board. It just gets frustrating at times.
That is what I was wondering. I am not smart enough to know the answer to that:)
Weird how the pre market trading has just stopped for the last 45 minutes? Would think there would be some action either way on a day like today.
If they do not give out some new data/news at this conference, in my opinion they were completely misleading with their PR about their involvement in this conference saying that there would be "EXCLUSIVE UPDATES" IMHO.
Copy that. They sure have a thing for the dramatic flair.
He was talking about the conference in Germany tomorrow. At least that was the link in the post I was referring to.
I must say even with me being in this stock for over 2 years. I will be shocked if they do not put out a PR today. I will just try and be positive.
She is not giving a talk at this conference. She is just doing a 5 minute introduction.
The link you sent is not a talk. It is a poster. Basically a poster sitting in hall with dozens of other posters with one of the authors standing next to it answering individual questions if people have them. Not a place to present new information.
If there was something new from the talk wouldn't they have to have PR'd it by now??
Chris that is what I am hoping for. I agree that news alone should have a significant effect on share price. If it is the case that the trial is full and they are just waiting on events I really hope they would share that with the public. I think investors deserve to know that. News of a fully enrolled phase 3 study waiting for data to mature, one or more combo deals, data from direct and information arms, possible investigation findings would make this way more than a healthy stock again in my opinion. It would make financing a hell of a lot easier too. So we wait and see.
I was shocked here in California when I got up at 6:40 and saw 3 million shares had traded. I just cannot imagine this happening again tomorrow. I would have never expected a day like today, this many days before the conference.
Don't see that on Nasdaq. Only says 500 shares at 5:30. Would love it if Nasdaq made the mistake not Etrade.
Hey Koman, I think it one of many possibilities. I think this is so because they are nearly or fully enrolled right now with the pipeline of patients they had before the screening halt. Meaningful data can be derived if that is the case. Can't say I know, sure wish I did. I see it as a disaster if some good news is not given out in the next 2-4weeks. I give unblinding as a possibility. Will it be combination trials? Direct update? Long term information arm date? Investigation update? Nasdaq issue update? I think it will be a combination of these. Just trying to understand if unblinding happens, what would be the immediate effect? No one seems to want to answer. I really have no clue what it would be.
Not to copy you, but I noticed that too. Not a very positive guy:)
I was hoping someone with the knowledge could try answer a question for me. If there is some unblinding of data in September, which I think is highly possible, what would it be? Would it be the pseudoprogressors subgroup? Or would it be the phase 3 trial? Also, if they unblind what kind of implication would that have in terms of data release in the short term and medium term? It is hard for me to believe they can do a final analysis of the data with the probable overall survival that we are seeing. I do believe it is highly likely they have hit the progression free events though.
Thank you to whoever chimes in:)
Hey Mav,
I don't see that she is actually presenting there. She seems to only be doing the introduction. Can't say much if she does not speak. She does have a significant amount of time to speak at SMI though.
HI Doc,
I was hoping you or someone else with the knowledge could try answer a question for me. If there is some unblinding of data in September, which I think is highly possible, what would it be? Would it be the pseudoprogressors subgroup? Or would it be the phase 3 trial? Also, if they unblind what kind of implication would that have in terms of credibility and share price in the short term and medium term? It is hard for me to believe they can do a final analysis of the data with the probable overall survival that we are seeing. I do believe it is highly likely they have hit the progression free events though.
Thank you to whoever chimes in:)
Hey Chris, I have been wanting to believe that they are seeking approval over the past year as well. There is just no other logical reason for such a long screening hold/silence from the company in my opinion. One of the things that has been difficult for me to rationalize is why then has not DCVax been the subject of any Advisory Board Meetings held by the FDA since the halt. My impression has been that these are the approval meetings and they are open to the public for anyone to attend. Is there another way to get approval? Does every new treatment NOT have to go through this process? If there is another way what is it? Not trying to bash but just to understand. It would definitely ease some of my concern if there was a solid answer to that question for me. Anyone who understands this process, I would love to hear what you know. Thx.
A small positive article on NWBO linked below. Funny how there have been 2 positive articles on NWBO in the past week. Have not seen that since I started investing 2 years ago. I realize it is not Forbes but it's a start. More to come? Hope so. I actually give up trying to guess any more. I trust the science and will believe management is doing what is best as frustrating as it is(understatement).
http://smallcapexclusive.com/northwest-biotherapeutics-inc-nasdaqnwbo-shares-down-but-not-out/
Hey TC,
I might be saying this to make myself feel better because I own a lot of January options. Lets just say a double digit percent of the total January 10 options(makes me look like a fool I know, but I don't lie). If you actually look at the open interest of all the January options it is really not that many shares when considering short covering. At least the way it looks to me. The total is about 5 million shares. Only about half of the true short number and not even a drop of water in the bucket if there is naked shorting like some think. Just you and I drop the open interest quite a bit because we are not hedging. I personally a few other people out there with $10 calls in the hundreds of option contracts. I just don't see it being that big of a concern from what I know. Unless I am reading the open interest wrong? Please correct me if that is the case.
Take care