good for you blew boy! Hedge funds in this company? funny shote. BTW kummstain I worked for a private equity firm but hey good luck!!!!! I don't think I'll try and explain p values to a brilliant guy like you!!!
You don't get it cupcake. They can be sued in the US but my little donkey, listen carefully the principals and the company are domiciled in in Canada and thus largely beyond the reach of US authorities so collecting on any judgment is virtually impossible. Don't ever presume to talk law to me.
a) this is not a registration trial and never was. The company was not clear in sending this message sooooo up to a certain point it doesn't make a tremendous amount of difference what the p value is. All the P value tells you is that you can't be very confident in the 3 months survival difference at this point in time. BUT BTW you can be verrry confident that PFS is increased by 3 months. Once additional data comes in on OS you will become more certain. This is a statistical certainty (axiomatic). IF the OS data holds (or gets better) the trial will have resulted in a decent p value ((perhaps (but unlikely) even stat sig)) and a CLINICAL signal of a 3 month improvement in OS. That will be good enough for the FDA to approve a p3 REGISTRATION trial. If you think 3 months is good enough to get approved (and I do since temodar was approved on 2.5 month improvement in OS) then 107 has a good chance or ultimately being approved. I took a small hit until the mkt settles itself out but I will be going long again very soon. There will b nothing but good news forthcoming in the next 3 months or so. P value will come down and OS will move right. Mark this post.
The ONLY info likely to come out of the interim data analysis by the DMC is "continue on with the trial" NO PFS or OS data will be forthcoming. Based on what I have seen on this board and the complete lack of understanding of what the interim report is supposed to accomplish, the market is likely to see this type of announcement as bad news even though would be good. That said, there is a very small chance that the trial will stopped for futility or stopped because of overwhelming efficacy. The former would be a disaster, the latter an immediate tripe in the stock.
I am long but I doubt that p-iii results will be as favorable as p1- Would be nice but again---unlikely. I agree with you, 6 month extension in PFS is hardly conservative in GBM and they should start managing expectations or face IMUC's fate when favorable but not spectacular data is viewed as failure. Thx for Liau's article I was unaware of it and seems like a bit of good news. And lastly rather than respond to shareholders questions about IMUV with a PR maybe they could provide more transparent enrollment numbers. I don't even think they have a quarterly conference call. Their steadfast refusal to provide enrollment numbers is puzzling since I don't see how it hurts them and it might help them. It's true that Pfizer et al don't report enrollment numbers but they aren't Pfizer now are they.
More encouraging data from early stage DC trials. They don't give you many particulars so it's hard to compare but they seem to focus on il-12. NWBO's approach probably overlaps Avx in many respects in that lysing patient own tumors probably extracts il-12 fractions as well. I think IMUC's does as well but its synthetically derived.
The IMUC data is encouraging. a) OS improved by 2 or 3 months, 57 people still alive and 21 not even progressed, all with at least 15 months on study. Stop and think about that for second. 57 on study for a minimum of 15 months and 21 progression free in a patient group that has a median life expectancy of 15 months. It's really kind of remarkable. IMUC simply botched the trial design and the PR. Powering for a 9 month increase in OS was absolutely senseless. Powering it for such a large increase in OS required them to unblind at 67 deaths. Not even half of the treatment group has passed on. This results in a very high p value but ignores the fact that the clinical results were promising. If they had targeted say a 4 month improvement they would have waited for somewhere around 90 deaths before unblinding and would have had a much lower P value and perhaps even stat sig. As is stands if there is really a 3 mo (or 2 if you want to use ITT) difference in OS, it can be made to be stat sig with a trial size of about 500 patients or so. And an improvement of 3 mod is enough to get approved.
All this is good news for NWBO. Although the two companies have very different approaches the4 IMUC results bode well for DC the therapy. and NWBI is a LOT further along in the process.
He's doesn't really understand Kaplan Meier curves all that well. Unquestionably IMUC handled the run up to the data release about as poorly as a company could. They set a senseless and wildly optimistic endpoint which necessitated the premature release of the OS data and the previous CEO dissembled on the status of the trial which hurt their cred. That said what remains is this; at 67 events not even half of the treatment arm has passed on ( somewhere between 33-38 of the 67 were in the treatment arm). so the signal to noise (p- value) is very high. Even if the median OS does not move a day, it is a certainty that the p value will decline as data comes in and may, in fact, reach stat sig. He also doesn't seem to quite understand how censored patients are treated. The 7 pts who left the trail a) left early and b) represents a large percentage of the 67 events observed. When a pt stops reporting or leaves a trial there are three ways to count them and there is NO std. way. First, they can considered dead on the date they didn't dhow up for an appt., second they can be treated as of the last date they were seen and finally they can be considered dead in the mid point between the points. IMUC chose the most conservative of the three by assuming they passed away on the last date they were seen alive. This can make as much as an 8 week difference in OS simply by the manner in which the company chooses to report the data and remember under all three options the patients are considered dead even though they may not be dead. Per protocol analysis introduces the possibility of bias but is probably a better in indicator of clinical effect. A 3 month improvement in OS (with the possibility of improvement as the data matures is more than enough to get FDA approval.
There are still77 people alive after 1In the coming months you will see the IMUC data get significantly better -much lower p value and longer OS and very likely in the "long tail: Take it to the bank
To be fair she has no real money of her own in the deal whatever she has , is a consequence of option grants. She has also take a few mill in cash as salary.
Lots of misinformation on this board-- a) No one has been pretreated so all that nonsense goes out the window-- You could look for yourself on the clinical trials.gov website for inclusion criteria. In addition, the company is NOT blind to the clinical data, they are blind only to treatment arm assignment.
All the other questions and rants about sub types, biomarkers etc are interesting but irrelevant. That isn't NWBO's approach so get used to it or design your own trial or pick another dendritic cell therapy like IMUC's. NWBO is using partially matured DC's exposed to pts own tumor--- period. They are well aware of the plasticity of DC's and believe that partially mature DC's will generate an immune response and not a regulatory response.
You can always Monday morning q-back the trial design, which I believe was too aggressive. The reason they unblinded at 67 events was because they powered it for a 9 month increase in OS if they had modeled say a 5 month increase they would have had to wait for more events. Remember p is function of sample size AND magnitude of effect. The larger the magnitude the fewer data points needed, the smaller the magnitude the larger the sample in order to show stat sig. The good news is you can now buy a very very promising treatment for a buck a share. Take this to the bank-there will be many bits of good news forthcoming before any possible bad news. OS data swill get better, subgroup likely to show certain pts who respond better. EOP2. P3 trial design.
I can see you're not gonna get it. The rest of the p2 data is largely irrelevant. The P3 design will NOT based on complete p2 data. It will be based on the data they have in hand shortly after the FDA EOP2 meeting. Have fun!!!!
Listening to the cc would stop you from making inaccurate statements End of p2 will be held in the first half p3 shortly thereafter. They will have 3 or 4 more months of data for the EOP2 - Data need not be complete in order to design the p3. Trial was powered to 80% at 67 events--done-- clinical signal established.
Funny how everyone is either still in the green or down just a little. Based on the 8 year history of the stock price you'd have to be pretty nimble to be down only a little. And of course "a little" is a subjective term. As far as confidence in our respective opinions the feeling is reciprocal. Of course you 're not as good an indicator as the drool bucket crowd like Armed lunatic Bailey or Kenny. Nome's 100% miss on OS is helpful too. I take solve in the 1PR reported in the Panc trial and of course the elephant in the room, the failed p3-- Gonna be a lean xmas but hey look on the bright side- Coal doesn't cost much