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Starts to look like market/institution believe they fail in the phase 3. Every up in stock price is being taken advantage to sell
Am i understanding it right? One patient is still alive with no tumor signs of rgbm over 3 years after vb111 monotherapy ? Today pr
Dropout calculations ? I remember I read somewhere but can't recall how many treatment of vb111 required in order to enter the statistics. Example somebody received 2 times vb111 and quit the trial.
Even if we take the average number 24.6% we get to zero % chance to fail in the ph3. What is the chance to increase overall survival in rgbm ? So far 82 out of 82 trials fail so let's assume the chance in phase 2 is not 0 but 0.3% . We have now 24.6% to pass ovarian 24.6% to pass thyroid and 0.3% to pass rgbm . What is the chance a drug passed all 3 of them together and it happened by luck ? Zero % chance
There is a connection between survival rate and chance to pass trial. Look at the numbers. In general the toughest the cancer the less chance u have to pass the phase 2 .scroll down to phase 3 chance ovarian has less than 30% while average is 40% . It's true that this connection is not in every cancer but in general we can assume that.
Take the data of less than 10% chance to pass the phase 2 in average in the 3 indication and add the fact vb111 passed all 3 and met primary endpoint it leaves u with zero chance to fail in the phase 3.the higher the chance to pass the ph2 the higher the chance it happened because of luck and not biological activity. The lower the chance to pass the phase 2 then the lower the chance that if u pass all 3 phase 2 luck was the reason
In general what i mean to say the 24.6% success rate is an average number that take all cancer types into consideration but if u want to look deeper to the specific cancers vbl is dealing u reach less than 10% chance to pass
I m afraid you didn't get my point. I don't talk about survival. Go to the pdf file u found the info search in document the word pancreatic. It will be showed 2 times...
"The solid tumor Phase III transition success rate (34.2%, n=260) ended up as the lowest for any of the major disease categories
studied. Solid tumor drugs for pancreatic cancer seemed to have the toughest challenges in Phase III studies (13.3%, n=15).
However, Phase III success rates for Ovarian and Gastric cancers also fell below 30%. "
Now this is what I did. Since 13.3% out of average 40% of phase 3 success is 1/3 I took the 1/3 And used it in the phase 2 average which is 24% so 1/3 of 24 is 8 so approximately 8% to pass phase 2 but it's not true it's around 4% or 5% because ph3 is easier to pass so it's not linear and it should be less than 1/3 but I assumed linear comparison . Do u understand what I did ? Since the pdf has specific info of chance of success in ph3 per cancer type but missing the info of phase 2 success in SPECIFIC CANCER TYPE I just took the relative numbers and assumed linear but it's not linear
And we don't talk about small sample. Small sample can explain rare results but here the sample is not small. We have success in around 170 and ovarian wasn't just a success but big success. Not only the sample is far from being small the cancer types say everything . Ovarian is a deadly disease u have around 6 months to live in platinum resistant it's not in the friendly cancer category . Ovarian is a very very devastating disease . Vb111 not only passed the sample size it passed also the cancer types but most of all it worked in 3 different cancers 3 phase twos passed . It leaves zero chance to fail in phase 3
I cant even think of a possibility that vb111 will fail the interim analysis. The interim is after 105 events and 1 year treatment to half patients this is plenty of time for the drug to work. I saw mri of patients on their drug. Metastasis disappeared and some patients showed tumor totally disappeared . They had a patient in phase 1 that the tumor disappeared after first treatment and didn't come back for years. When they were at even not middle phase 2 the fda looked at the MRI and said they never see anything like that before in rgbm and urged them to start ph3 before finishing the ph2. Results like that in the ph2 is around 0.something% chance . Looking at past phase 2 there were over 70 none showed that not even 1/70 so what is the real chance of such success in rgbm ? And u want to tell me it won't pass the interim. Are u kidding me? Zero chance
I think you brought these numbers from clinical success rate 2006-2015 pdf in google search but if u look deeper into the numbers although u are right that the average success rate in oncology in phase 2 is 24.6% this is average and not applicable to the cancers vblt deal with. If u look at phase 3 success the average is 40% but pancreatic has 13% success and ovarian is under 30%. I took these 2 phase 3 and went to phase 2 assuming same relative numbers my numbers of less than 10% make sense. Ovarian on his own is less than 20% in ph2 usong relative numbers but we dont deal with ovarian we deal with platinum resistant ovarian and in this subgroup vblt had great success in refractory platinum resistant which take us to less than 10% success rate. Gbm is lets say same as pancreatic the hardest of the hard which takes us to less than 10% but we dont deal with gbm we deal with recurrent gbm which is worse so less than 10% chance is being conservative. Then we have thyroid but it is not really thyroid its a very rare aggressive type thyroid that overcome all treatments including most advanced again less than 10% chance...
And just remember one of the reasons trump won is weak opponent. Avastin is very easy to beat. Except of some deadly side effect and provoking the cancer it does nothing. I can beat avastin with some change in diet positive thinking cannabis and whiskey . I continue to be vblt chicken the CEO is also a chicken but from the other type.
I think u made a mistake selling vblt. The reason is that with drugs stocks I close all doors and pretend I m machine checking for biological activity. The drug doesn't understand risk fear maybe failure success ...the drug understand only biological activity and u did a math mistake as well. U left ur shares exposed to multiple ph2 that the chance to pass at these cancer is less than 10% while the chance to pass the phase 3 is 7 times higher. Usually ph3 chance is 2 times higher but here due to 3 succesful phase 2 by same drug the chance of ph3 is 7 times higher. Biological activity remind me of Marlon brando in Stella adler school of acting. One time the teacher says now I want everybody to pretend u are a chicken and a bomb is suppose to land in 30 seconds. Everybody in class starting doing crazy panic chicken in trouble noise except of Marlon he just lied on the floor doing nothing. The teacher asked him what's up Marlon a bomb is going to land ...he said I m a chicken what do I understand about bombs ?
I m not saying vbl is a charity institution when I say let people pay 50000 I think vbl will make more money...we are not charity institution we are vbl
If they are smart they charge only 50000 . The days of expensive drugs in cancer is close to an end. Remember it's combination drug also being ethic is not bad.
The original prediction of company to 92 events was end of 2016 then it became the beginning of 2017 and the trigger according to selloff hit 21 march. It shows me a delay in interim . 21 of march is not the begin of 2017 and not the end of 16 its more like mid 17
Yes. The person may have reacted in irrational way due to around a million dollar he had in the stock and sold everything pressing market. During that day the same person was selling I remember it was obvious there is a seller but at the end he lost his patience. Maybe because he suspected the info he has couple of more people have and the stock will go down in coming days anyway so he should run away and fast and even sell at 4.2. Somebody who invest a million dollar in a company like vblt is not just another investor this is why I m not fond of the margin call story although I don't know .
The selloff in tenx was very close to failure announcement. Assuming it was a leak in vblt in march the seller knew there is no rush to sell therefore it doesn't explain how fast and at any price he got rid of his stock. The margin call theory make more sense although everything is possible
This is very interesting . leak from blinded data caused the selloff in march. We know the safety committee that see blinded data gathered in march. So now we have many signs of failure. I m also invested in tenx and there was similar selloff due to probably leak before they announced the failed phase 3 leaving me with huge loss. I still believe by the way tenx drug will be approved by fda although trial partially failed. Back to vblt ...so we have all the reason to run away but I stay why ? I know that at some point unfortunately people in the avastin arm will die one after another because avastin provoke the cancer to such an extent that when it overcome avastin it kills the patient fast
If no clue. What was the trigger of safety analysis in other trials like celdex trial ? I won't be surprised if there is similarity between trials. CEO of vbl mentioned celdex trial as a potential success in 2015 so he may have designed the trial in some ways the same
Trigger of safety analysis. There were 2 so far. I remember the diagram demonstrating the globe trial had some lines that probably stand for something ...does anyone have a clue how many events triggered the first safety and second. Do u think the changes the company did to interim analysis trigger and topline also included changes of safety tests trigger?
There is no doubt the impression came from the ceo is fear. He is nervous and worried . The change in interim analysis trigger is just one example but I say again even if the ceo call me in the middle of night saying he thinks I should sell and it's going to fail I m not selling. The cliff type deterioration of avastin will take place eventually (unfortunately) in control and the advantage of vb111 will be prominent at that point . Inspire, Facebook sharing ... most of the people in these forums announced a war against rgbm and jump from treatment to treatment sometimes doing wrong decisions....with all the pain of reading what they go through I won't sell even if they call me . From many reasons that I mentioned in the past vb111 won't be just a success but a big success although if they used other drugs to combine or monotherapy the results be better
I search 7 may pr or other sources from the convention in Switzerland. Found nothing. Has anybody found info from the failed bristol mayers trial in gbm compared to avastin. We can learn I believe much from this trial but although they promised to publish info I couldn't find any details of this trial opdivo vs avastin the blind is leading the blind
Surprising the cancer ur thoughts. Do u think that sporadic treatment will be more effective than every 2 week or 2 months treatment because in this way u surprise the tumor while if u give it every certain amount of time the brain is prepared and signal the body including tumor soon medication time . medication time to cancer is not the way to win a war.
All the nice spiders they show u are from people who reacted with fever. People who didn't lived expected avastin only period. If they show u spiders of non fever patients it would look horrible. I already told CEO his drug work only because of the immune response and I offered him to use soup of viruses as vectors and not just one type of virus and in this way increase the fever response.
I said if . hypothetically
Where did they put asco abstract it was supposed to be publish may 17. I believe in vb111 especially because of the immune arm. I believe only this arm actually increase overall survival and nothing else.
I m not selling. Even if CEO scared to death from failing due to info he gets from people involved. I believe that what will win will be the biological activity of vb111 vs cancer biology
Ieant the CEO received bad feedback and then decided to change trigger and also decided not to do spa anymore in ovarian
Worrying about globe trial. There are some signs received feedback a while ago the trial is not doing well even 3 signs. First sign was changing the trigger for interim and final. Second sign is refusing the spa. Probably vblt wanted to do a similar to ph2 globe trial with people starting only on vb112 and only later move to avastin but fda refused and they blame the fda and spa for the globe results they heard ... From seeing how this CEO thinks I still believe it will be a success because this CEO is always in fear of failing and I think he himself is too worried about the trial and vb111 although combined with avastin that disturb vb111 by provoking the cancer or by killing the nicer sells leaving vb111 with provoked more aggressive cancer. Even with it on his back I believe vb111 will win but it looks scary.
I take a break from forums. The trial in rgbm will meet the primary endpoint not 99% it's by 100% zero doubt. I just believe the results could have been better without avastin. 2 reasons - 1. The complete responder that lived 2 years and 7 months was on vb111 only. 2- the reason there was a progression after first or second dose of vb111 is because the arm of vb111 which is not immune arm starts to work only after 4 or 5 treatments and this progression is not a sign that somebody may learn avastin combo is required.
Vbl broke a history record. They hold the first time of the history of human being a completed trial that showed overall survival of over 14 months in rgbm. So they already broke the record in phase 2
With all being said have to remember 1 thing. 32 experimental drugs failed in rgbm. FDA quoted saying when they saw vblt phase 2 result "We have never seen results like this in rgbm before" they were so amazed by what they saw they urged vbl to start the ph3 even before the ph2 is completed.
It's a huge mistake to make the ph3 different from a successful phase 2 can u explain why ? I m telling u all this change will blow everything. It can even cause not reaching endpoint and even if they meet the results will be poor. Why to change ? Is there a reason?
I think the phase 3 is not similar to ph2. I won't be surprised to see a huge failure or very weak results. How stupid can the company be to design a different trial while they have a successful phase 2 in hand that u only need to repeat it. Unfortunately the avastin will kill the patients in both arms not letting the vb111 express itself are much less than it should be. The complete responder u were talking about stopped being a complete responder because of the avastin if the vb111 was given to him as mono like the phase 2 he would have still be complete responders. The avastin provoke the cancer making him much much more aggressive and deadly. Even a donkey understand that and many of the patients and doctors. Vbl is a huge disappointment not repeating the phase 2 with no changes.
Is the ph3 identical to the ph2? If yes then no worries it will meet primary endpoint. If not identical be worried. As far as I remember in ph2 treatment arm people get only vb111 as monotherapy and only upon progression they add avastin.is it the same in the ph3?
This news is meaningless. We already know from over 150 patients for 17 years that the drug is safe. I believe the stock shouldn't react much but market thinks different this is why I call market stupid and myself less stupid than market. The only news is that vb111 is the only substance on earth that have a very good chance to increase survival in rgbm so far except surgery and radiation the drugs do more damage than helping - all of them.
The only thing that can help us from these failed trials is...in bristol failed trial what was the overall survival in avastin arm ? These both drugs are useless and can't be compared to vb-111
They chose avastin as combo and now they may use another useless drug for rgbm. Maybe this is the strategy you choose useless drug in this way u make sure control arm won't do well and trial succeed
They had money for 6 phase 1 and 3 phase 2 and now for another small ph2 and ph3 no money ? Nash has more value in terms of money than vb-111 . The ceo treat vb111 as if it's his baby - need to wake him up. I sent an email to management - these big pharma like to buy cheap with their billion small desperate companies. If it's me I don't talk to them before I have success in phase 3 .