Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I read something else. That he was free of cancer 4 years and then the recurrence in may 2016
Do u believe no 105 until 14 August if yes then of course we meet primary endpoint but I m not sure about it. Just raised the question and the fact somebody private message me he spoke to IR and he told him they didn't reach yet 105 and that they are not blinded to the number of events
Very sad. Even the patient they decided to show as success turned to be failure. He lived avastin period
The fact there were 2 changes so far in trial and both changes delayed data readout is worrying but at the same time showing fda is doing it's best to help this trial succeed. Right now avastin and vb111 I believe doing around the same but if fda decided to skip futility I believe there is small group in treatment arm that the mri shows great improvement and they believe more delays may cause statistical significant advantage of vb111. Even if we will see success I believe due to what's happening it will be a modest success but I may be wrong
I assumed 105 events occurred a while ago and ignored this info from IR. The reason I posted here is to hear opinion about this IR comment
I didn't speak to IR myself but somebody who spoke to him sent me private message saying that up to 14 of August the day of q2 results 105 deaths didn't occur yet. If this is true and I have no way to verify it unless somebody else spoke to IR but if true 189 events by end of year sound too early to me. The question is if fda plan to stop the trial early because vbl said in conference call that based with the talks with fda the top line data is planned begin 2018
I think I misunderstood the sentence in press release and it is not what I thought. And no info was given from the blind data at least according to this sentence
Yes it's from unblinded people. The problem is the market doesn't believe this company. If market thinks dror haratz was really told by fda it's on the way to be approved based on blinded data we were already at over a billion market capacity. The market believe dror is lying
Davidal. Instead of u and any body with a brain I would buy vblt without looking back. They can't say it in press release if the fda didn't tell them that
"Based on our interactions with the FDA and the SPA for the trial, the GLOBE study should support a Biologics License Application (BLA)." Sounds like in phone calls and meeting fda already told them vb111 is going to be approved. Am I right ?
189 death when ? 75% of patience being treated for 12 month will happen end October according to CEO in last call . He said most patients were recruited by November. But when will we have 189 death ? This can be delayed to may June 2018 no ? He said 90 days interim results analysis maybe he meant to line data analysis ?so it can easily delay the results to 2nd quarter even 3rd 2018
Vb111 will be approved although
1. Combining with Avastin- WRONG
Avastin hurt all cells including immune
2. Combining OVAL trial with useless worthless harming immunosuppressive chemotherapy- WRONG
3. Not repeating ph2 in ph3. WRONG
4. Treating fever WRONGEST
5. Dosage. They need to increase dose
The reason they don't know is because they don't have experts from immunotherapy field
They don't know what they are doing. If I m in charge this trial was stopped already for efficacy
The higher the fever the longer they live. This is from the article I published few days ago. Specifically to vb111 no info because the company didn't do such analysis if I was in charge there would be such. Reducing the fever disturb the immune response it's obvious.
https://www.sciencedaily.com/releases/2011/11/111101130200.htm
If u have time look for Dr Badylak regenerative medicine lectures in youtube . He is a veterinary dvm degree and phd in science and also MD . What is impressing about him is not his degrees but his attitude as a doctor. He consider all they teach in university and doctor books as may be it's correct and maybe it's wrong. I listened to him because I m poorly invested in a company called Biostage. It's an early stage company but one that have experience with human. If Dr badylak find vb111 accidentally work in a way he didn't program he will leave all he thought before and concentrate on that but most people will go about what they believe. DROR invented vb111 like many human invented drugs to cancer and somebody invented avastin guess what happened to all human who invented cancer drugs ? They all failed. Now let's look at the immune system . Did they fail.fighting cancer ? They never fail unless the cancer does a trick and then they fail but if u expose the cancer again to them they will do the job and in some case
s cure the cancer. So what do u prefer ? Letting the immune system do it or insist on we human do it and then maximum you live a bit longer. Unfortunately human think they can do better I give u another example . Where is the hype now in cancer immunotherapy ? Car-T why the hype is there and not the active approach of vb111 ? Car t is intervention of human in the immune response people like it wow we program the t cells sounds very cool while the vblt gnca another stock approach is we don't do it we just bring the immune system to the area and watch. The hype is not there because we human like the thinking wrong thinking that we can do it while we can't. We human are not programmed to fight cancer while the immune system is programmed and do it successfully every day. Look at dror did he knew that he is going to invent a virus that bring immune system to fight the tumor ? No . He thought he found a cool way to kill the cancer antiangiogenesis the immune scene was a surprise. Instead of jumping on the immune scene and understand it's the main cure at least to my opinion he continued to be so proud about the beautiful mechanism of the angiogenesis drug. The proof to me of his lack of understanding his drug is the combination with chemo and treating the fever.
I m not spamming anybody with my emails. I had a discussion with them in the past and any comment that can help is most welcome by anybody including the company. There is basic common sense . If u know patients with 37 c lives 6 months and people with 37.5 lives 6 months and people with 38 lives 9 months and people with 40 c lives 24 months on average. Does it make sense to reduce their fever by other drugs ? Maybe it makes more sense to avoid treating unless it cause severe risk and even then to treat mildly and not just until the patient feels no fever ? Don't u see that treating the fever may kill them earlier?
I published this response in seeking alpha and I think it may represent the options we have although of course I can be wrong
And one big thing I forgot to mention. If you check last pr and conference call earning you will surprised to hear that FDA decided to cancel futility analysis. Very weird , I never heard of SPA FDA trial that they decide to cancel futility analysis. It was suppose to happen in September 2017. Celdex tried a drug in ph3, did the FDA cancel futility ? No. Bristol Myers and much bigger company than VBL did they cancel futility ? No. actually I don't remember even one case that FDA decided to cancel futility analysis and jump directly to the top line data.
I am asking myself why did it happen here are the options:
First I tell you what it is not, it is not that VB-111 working great. If it was working so great they would say lets do futility and in the futility they would announce they stop the trial because VB-111 is doing so well. so this is not the case. VB-111 struggle with rgbm it is not winning in knock out
So what could it be ? and why the market took the stock from 4-5 in few days just because FDA cancel futility ?
1. It can be because the FDA is lazy like me. It can happen. Why to do futility now if we are so closed to the end of the trial BUT in order for this reason to be valid VB-111 must be a bit better or not less than avastin, if vb-111 was doing less than avastin they would never press the laziness button
2. They are not lazy but they see something. They see that VB-111 helps only to small group of patients but it helps them so well that the MRI show very small tumor and maybe even lack of tumor while in the avastin group they don't see anything but same as historical activity in the MRI. so they see that if they do futility now it is not fair for the drug and it shows the FDA is doing all they can to approve VB-111 and right now the way to do it is by canceling futility hoping the small group will live so long that it will affect in a positive way the top line data. A clue to that option we have in the last PR of the company if you look at the earning PR they speak about the long term effect of VB-111 look how many time the word long term is in the PR. It is an EYE wink from the fda and the market understood this clue by fda and company talking about long term survival by VB-111
So anyway I look at it we have here a drug that FDA is doing everything possible to approve and when the power decide to approve it who am I or you to decide ? They approved avastin only because they wanted to and it seems they want to approve VB-111
The fact they treated the fever in ph2 is not relevant. Also the fact they mixed immunotherapy drug with chemotherapy is not relevant. These 2 are both mistakes. Pls read the article I published few days ago and see how foolish u have to be to treat the fever. What chemotherapy mean ? What treating fever mean ? It means u disturb the immune system from working . And what is fighting the cancer in vb111 ? The immune system. Isn't it foolish ? There are no swings . I m trying to be objective . Most people feel easier of having one side they support I try to avoid that.
What a huge mistake to treat the fever. I feel sorry for the patients being put in their hands - terrible.
Time to start buy bstg with big money . There may be rs so leave more money to buy if needed later. The change to esophageal athresia is correct. These babies need series of surgeries not like cancer that is usually one and in cancer standard of care has an answer not a good one but an answer. Here the answer very weak because series of surgeries. The value of biostage is going to rise sharply. Big money buys is the correct move expect the stock yo go up sharp very soon. There is no way market don't understand what I understand
The future OVAL study just show me how stupid vbl still are and how they don't understand how to use their drug. Instead of mono vb111 vs chemotherapy they mix it with chemo which is a well known immunosuppresant. Look at the following sentence from article I published in previous message
The disturbance of tumor such as biopsy and surgical procedures cause a greatly increased number of cancer cells to enter the bloodstream, while most medical intervention (especially chemotherapy) suppresses the immune system. This combination is a recipe for disaster
What is the chance the patients in trial are not instructed that fever is part of vb111 cure and them taking otc drugs to reduce fever ?
What is the chance the trial centers doctors themselves give the patience treatment to reduce the fever ?
It is a shame if one of the two happening.
Why I am worried ? Because doctors have no clue how to fight cancer. Read this article it says it clearly:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3312698/
I also hope vbl will do analysis of exact mean fever temperature comparing to cancer progress and not just fever or no fever
First time I hear dror speaking in earning call about geographical agreement that he works on to bring millions without dilution. I won't be surprised about news this year
I may be super wrong and I have no problem with it. It may just simple like company says
Fda decision to cancel futility support ur old claim that if there was one it would fail. Dror said there may be some non dilution cash and agreement he tries to arrange. This is the first time he says it in earning call. Maybe it's tome to buy vblt again because any agreement that bring cash nash or vb111 will jump the stock
No sir haha . It's funny I think I got it. FDA WANTS THIS DRUG APPROVED. I can't explain it otherwise. Have u heard of fda skipping futility ? I have never heard that. Did u see how many times company says long term in this pr and lately ? The fda agree with them and want to approve it based on this long term to small group. It's so obvious and the market understood this eye wink from fda. They want this drug approved this is why u see what u see. It's bad news today . Why stock up ? Because it's so bad that it's hard to believe the fda skipping futility that make market understand they fda simply wants it approved no matter what
The company keep talking about long term benefits from vb111 also in the q2 pr giving us a huge clue about what u said and about the cancel of futility analysis. The drug will be approved based on long term effect of small amount of patients. This is what they believe and the fda agree with them and this is why we see more and more delays. First it was 91 events then 105 plus 50% now they came with more delays with a funny excuse - the reason of this current delay IS the previous delay that brought the interim so closed to the end of trial that there is no reason to even do it.
Thank u for the reply
The way I understand it. Correct me why I m wrong. The fda see that if it has to do futility interim the recommendation will be to stop the trial because vb111 is doing the same as avastin. Because the fda wants to help vbl pass this trial (like they did with avastin approving although useless) they want to give it more chance and more time . The fda probably know the cliff phenomenon in avastin and maybe they believe this cliff didn't arrive yet they want to cancel futility to give vbl a chance. I saw it bad news from the beginning and I still think it's bad news although the market think different. People here and other forums feel different. And except the girl that asked him in conference call suspecting there is more to the story that for hides nobody suspected a thing while this girl and me suspect. The girl asked " is there anything beyond that which u don't share with us "
Davidal pls ur impression if u are still interested in vbl ? Did u buy today or still watching ? I m very confused . One just private message me that he spoke to external IR and he or she told him that they are not blinded about number of death and that 105 death didn't happen yet. I highly doubt this info because if no 105 death why for said the cutoff data is in August?
Bad news ? Or very bad ?
If interim success but the word unanimously is missing . It's very bad sign. It shows weak border line results agree ?
From inspire cases. Anybody know how many witness fever and was the fever in every vb111 treatment or just the first one. I know of one case in inspire that the doctor recommended him to quit the trial and there was no fever response
Assuming avastin lived in median 10 month and vb111 combo lived 14 months how many death so far until August?
Does anybody know a personal email of somebody in biostage like jim the ceo i have a case study i wish to send them
Only September. I think I heard CEO saying it
They may be sued if ph3 fail. Very stupid thing to do . I doubt it was by mistake but small chance it was a mistake
It looks like they considered 4 weeks as one month. I still consider what they did as kind of cheating unless somebody come with sufficient explanation
I emailed him about my prospect about avastin. Him and all 3 doctors involved in this trial. Of course no reply but I m sure they saw my emails. I also emailed fda - avastin shouldn't be given to rgbm patients