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Corin statement is a bold clue to public big investors and doctors about what to expect to...the phase 3 is going to be a big success
Yes u are correct 15.7 is the median
I look at sep 17 pdf presentation . 15.7 is only one patient and I still see 810 days. Where did u see 15.7 as median ?
Don't be surprised to hear trial is being stopped early. My thoughts from the info I have take me there. I talk only from public data so far. Adding all together
May I ask what "ca" stands for in ur messages ?
Avastin is not anti tumor agent in many cancers and gbm is one of them. It just help with swelling and side effects from other medication cancer patients take. Avastin is like placebo in rgbm. The overall survival of avastin is dependent on number of patients and tumor size . Small amount of patients show 35% os after 12 month only because sample was small. In Bristol mayers trial the tumor was small in all patients so the mos was 10 months. Avastin is useless and a very good candidate to beat in rgbm
My calculations also show without any doubt primary endpoint met already this is why I believe that for the benefit of the people in trial they should stop it. They won't do it because we are few months before end of trial but there is a chance they will do it. My calculation is simple . Let's assume all patients started trial Oct 2016 while we know trial started aug2015. So I give a huge interval here . 1 year overall survival avastin is 25% alive 75% died. From 256 192 should die Oct 17 but we know only December or January 18 189 events occur...it means without any doubt primary endpoint was met again I took October 16 as the month all patients recruited while trial started over a year before!
https://www.novocure.com/novocure-announces-the-ef-14-phase-iii-clinical-trial-of-tumor-treating-fields-in-patients-with-newly-diagnosed-glioblastoma-has-been-terminated-at-the-interim-analysis-due-to-early-success/
Does anybody know some more details here ? Was it just safety scheduled meeting or futility meeting that was planned or was it something that was not planned and just dsmc deciding out of the blue to recommend stopping the trial. I believe the dsmc care only about patients interest if they believe vb111 combo is better than avastin alone they will recommend to stop even if it's only safety meeting ? Or no chance when no real interim data analysis ? This case can show dome light on stopping early in rgbm what are the standard of stopping early here I see 29% vs 43% os benefit that made them stop trial early
They said 2nd half of q3 for months. They confirmed late september couple times. What is the reason of delay for no news like that . It's only safety ?
At the beginning I also thought it can't be that 105 events didn't occur until q2 call in August 14 but from hearing the CEO now saying readout of data will be in q1 18 and then he says there may be a delay making me think may be 105 in August make sense. If I m CEO and 105 in August this is what I would say expected q1 with a small chance of delay... we tend as people not to believe but here there is a case somebody in the know the IR at the date of q2 call when he probably prepared himself before speaking to investors said 105 events in August so I start to think it may be true and I give it 50% chance even more. I think 105 in August make sense cutoff data of 189 will happen in q1 2018
I was discussing private message in stocktwit with a new user that came to invest in vblt he tried hard to reach IR without success. At the day of q2 pr and presentation he told me he was finally able to speak to IR on the phone and he or she told him that as of 17 of August 105 death didn't occur yet. I decided to ignore this information because it sounded too good to be true to me. In my mind was q1 presentation by CEO saying we know when we recruited patients and therefore we know the interim will be somewhere in the second half of q3. I believe that if in April ceo says that interim will be determined by the second condition of 50% and he didn't mentioned the 105 events I assumed we already reached 105 in April or we were very close to 105 in April when CEO determine we would have the interim in the second half of q2. If I do take the words of IR which may have said that because he knows then we talk a different story where 105 death didn't occur by August 17 which is big deal.
If until 20 August 2017 only around 105 events I don't see a reason why to continue . It's obvious the drug works wonder
But look at my assumption . We know half were recruited by mid August 2016 but 50 were already recruited by June 16 and we also know end of Oct 90% of patients were recruited even more....by me choosing September according to ur thesis since the 50 enrolled before June and since September is very close to the October full enrollment and since we know mid August was 50% again according to ur thesis and assuming my method the proof primary endpoint was already met is even stronger....in ur example u gave 2 far points of 50% March and March but look here we see 50 far from Sep and we see mid August very close to my Sep assumption and we see October which is also very close to my Sep chosen month to count.
Look at my last simple calculation how we know primary endpoint was met. If we assume 25% alive by now if all 256 lived avastin period meaning 75% sadly died then we already met primary endpoint. If we assume 65% sadly died giving avastin a lot of credit then primary endpoint will be met around December this year. And CEO said we are going to next year to reach 189 events so any way u look at it primary endpoint was or will be met
First of all since we are here to make money I think u should buy back the faster the better. It may go up without going back down and u will regret not listening to the side of u telling u to buy. I saw it in cpxx I saw it in tsro and even now in cbay. The plan to buy after they announce success is not a good idea here because its well known to too many primary endpoint was met. Even if avastin did 10 months we will meet primary endpoint. We can take Sep 2016 as average date 256 patients starting the trial. Assuming avastin is doing well 35% are still alive after 1 year and 65% died. This is the best u can give avastin so by September 2017 we should be at around 167 events out of 189 so it's around 14 events per month we should expect to reach 189 by mid October but CEO said in last interview from September 14 this year that event 189 events happen q1 2018 or later. It means we will meet primary endpoint even if avastin did very well
Of course they look into all factors. When u want to decide if a drug is safe or not u have to check benefit vs bad. If u have only the bad or only the benefit u can't decide . Need both
The people in the know have the data and the bio stat already made some research on the data in order to find out safety...be sure they know what's going on. If they see dec or Jan get to 189 the trial won't be stopped earlier but if the delay is bigger they won't wait until April for the 189 and stop it early . It's already obvious to u primary endpoint met . Do u think it's not obvious to people who see the data? Like u with no calculations ? Of course it's obvious to them too
Now that we all know primary endpoint is already met let's see where it goes. I think they should stop the trial and start treating everybody with vb111
Not imagination. Bristol mayers trial avastin was over 10 months. Also drop off from globe trial is a fact. They spoke about it and people went to other trials that may affect avastin result. I just say the 10.5 months in bristol and more trials may be from other reasons other than small tumor
You have to assume 10 months for avastin. There were drop off and they continued otger trials..also lately avastin shows nice results and maybe it's not because tumors were small
My mistake u are right. So if only in January 189 I agree - primary met
I also want success but there is a motive of fear throughout this ph3 . Fear of failure. The change of trigger from 91 events to 105 plus the other condition and then the fact company asked fda to cancel futility .It is a motive that repeat itself in various ways. I see now sadly in inspire and other sources people on vb111 arm that die after 8 9 or 10 months. Don't be so sure vb111 is doing so great. I think vb111 struggle because we talk about rgbm. I still believe there is small group that vb111 works very well for them even to an extent of tumor disappearing and this is why the fda agreed to cancel futility and agreed to change protocol to 189 events...of course I can be wrong but I think vb111 will be approved based on more than usual complete responders
Remember there are 2 condition to trigger top line not just 189 events. Even if 189 events happened in June the other condition stays and took one won't be triggered until November. I m not saying it's the situation but just to remind u
I assume from ur frequent writing that u bought back vblt ?
Where did u see the cutoff date was August 17. It's the first time I hear exact date of cutoff
I believe the rise is not connected as u said to the ph3
I will never forget CEO words in Hebrew my language that made me put tons of money in vblt. When it's in ur language it's easy to determine if he is truthful he said not only the phase 3 will be a success it's going to be a big success. He said that in August 2015.
I won't be surprised if the soldiers of the boss thai Lee brought down to sub 4 in August so the queen of bees can buy cheap. Thai Lee is a very smart girl and she never deal with bio. Billionaires have nothing enjoyable in bio stocks with low volume israeli small.... if her people sharp analyst told her not only u don't want to sell ur shares but to buy more says everything. Remember she received vblt stocks as a return of loan originally and didn't initiate buying it and the fact she adds while u expect her to sell...
In the ph2 they didn't adjust the results to cancer severity. Here in ph3 it should be adjusted. The control was healthier in ph2 and still vb111 did well and it was not adjusted in the results.
Not confused. In my mind there is always 2 scenarios of success big success failure ...this is why my view is not clear
189 events and 75% of patients get treatment 12 month can happen in November . U assume it happen in January but it's an assumption. If u listen to CEO not long ago he spoke about top line end of year or just at the beginning of next year. CEO also assume 60-90 days to calculate the stats and still says q1 18 knowing that even if cutoff was Nov 17 the pr will come only Jan or Feb 18
The comment of CEO in this last call that there are many patients living very long term together with comments almost in every call in different words that death rate is not high together with private message I received from somebody who spoke to IR saying the 105 event hasn't been reached by August 17 make me think vb111 is doing close to phase 2 results. There is no reason the results will be less.
I think the biggest hint of success is the fact vb111 met primary endpoints in 3 different phase 2 trials. 2 of the 3 are anong the hardest cancers that exist
I will show u a proof so we can bring an end to this argument. Go to the conference call not the last one but q1 conference call by Dror. Listen to when he says we know when we recruited each patient and we know the 50% will happen somewhere in q3. He doesn't talk about events why ? Because the event already occurred. If the 105 didn't occur yet how can he predict it will happen in q3 and why to mention the fact 50% 12 month will happen somewhere in q3 ? Here is the part u want to listen"We know when we recruited patients and of course we know when we are going to get to the 12 months follow up of half of the patients. And that's not going to happen before Q3 2017. "
I suggest u relax a bit it's not a war zone and who to believe or not to believe. U are newer to this company than me and I followed the dynamic of the recruitment. What I tell u about the recruitment is a fact and it was confirmed by IR I didn't speak myself to the IR but this specific info match the dynamic from inspire.com the trial started August 2015 but only in August 2016 50% were recruited . The recruitment was suppose to last to may 2017 but the word of mouth and hype caused peak recruitment happening starting June July 2016 and then from around August September October the other 50% were recruited. Even if I m wrong it's no big deal and don't have to make big deal out of it
The 5 month ahead of scheduled note support what I said. There was hype that brought in 3 months 50% of patients. It also supports top line end of year or begin next year because otherwise if 105 events just happened now how can 189 events happen by year end ? It's impossible but if u go according to my and other here estimation although of course I m at be wrong 105 death happened a while ago and not just in august
Yes I believe the 50% happened only in August. From August to December another 50% was enrolled. By Nov 2017 around 75% of patients had 1 year treat
I think u misunderstand the conditions. Both should happen if let's say there are 150 death but 50% of patients were not treated then we still wait for interim although 105 occurred. So when he says we are closed to that point of both conditions to be filled u don't know which condition hasn't been filled
Ok. It's not important vb-111 will be approved. It's already obvious the question is if they will be able to show some surprising results like the phase 2 or only 2 to 3 months better than avastin.