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Sorry I must’ve missed read that. I thought for sure I read in the proxy that if you didn’t vote that would equal voting with management. I’ll have to go back and re-look at it.
Danny.
No need to worry if you don’t vote that will Automatically equal and count as a yes vote.
Flip.
Wondering what you think regarding my thesis that the publication line was placed in the SEC investigation section on the 10K in order to deflect criticism away from management?
The SEC doesn’t give a crap about when the company decides to publish something in my opinion.
What that SEC cares about is the delisting from NASDAQ and not complying with NASDAQ rules and having the CEO have conflicts of interest.
It seems like a classic LP disinformation maneuver doesn’t it?
Do you think that’s a reasonable analysis more not?
You yourself have indicated that the publication is late. Correct?
They have been milking this publication unbelievably over the last year. Given very little information and just enough to keep people interested.
I’m tired of waiting for no reason.
Believe me I’m going to be pretty upset and frustrated further, when there is no LBA.
Exactly right good guy. Very insightful.
I think you’re right on. LP put the additional new information in the 10K regarding the SEC and the proposed blinded publication delay, only to shift blame away from herself and management, because she knows and the meager data that she has given us has shown, that this data is significantly positive.
She has known this since 2015, Or earlier. So management is culpable to shareholders for the last two years of dilution and share price collapse despite knowing they had positive results. Yet she steadfastly refuses, to the companies and shareholders detriment, unblind and review the topline data.
Heck, I have done the analysis myself and Clearly the trial will be positive based on my extensive reviews which you can search for on this board.
I think at the end of the day when management was formulating their 10K they added the line about the publication and made it seem like the SEC had some role in postponing it, basically to take the eye away from themselves and their own culpability.
Typical lawyer move, when your client is upset blame the government.
So when this ASCO arrives, and ends this year, with NWBO Again standing there naked and flat footed with absolutely nothing, No abstract, no presentation, nothing but a large booth that no one is Interacting with, they can say “it was the government And the SEC investigation, our hands were tied”.
What we are seeing again in the 10K is the smoke and mirrors continues, and the fancy lawyer language Thought process, persists.
I do hope that this analysis of mine Is overly cynical and incorrect. However it is consistent with LPs overall way she has previously interacted with shareholders and her overall previous communications with us, which have not been very accurate to say the least.
AI.
I don’t know. I have long since given up trying to understand LP and her motivations for things.
All I know is that using the currency of shares at this point in time with the share price so depressed in order To pay directors, is not very wise and is unfair to other shareholders.
I had to pay cold hard cash for my shares. I don’t like the directors getting freebies.
We have clearly demonstrated nearly a year ago, statistically, that there’s a very low almost negligible chance for statistical failure of this phase 3 trial, Given the meager data points that management has provided.
Please review my prior posts as I stand by my Kaplan-Meier survival curves, previously published on this board, even to this day, and have seen or heard of nothing that has changed that data.
Especially if you truly believe that you’re going to have an article soon, What’s the harm of just waiting and pay the directors with higher valued shares in the future?The directors still get paid, but they don’t become Multi multi millionaire’s off of it at our “regular” shareholders expense.
LP has made us all wait and suffer for nothing. The data is already positive.
I agree photonics. I always review your posts and really respect your thoughts.
Exactly how I voted. Yes no no.
While I want to reward the directors I think it’s unfair to do so now, using shares, at the very undervalued share price. Just wait until we have news which according to management should be shortly with a published article.
Then the directors can still be paid and use less shares. This would be more fair to long suffering retail shareholders. It just seems slimy now to give away free shares in the order of many millions at the current reduced price of the shares at this time.
I don’t like the preferred’s because I think it is just a gimmick way to hurt the regular shareholders.
Thanks smoky I will give it a try.
Worst case scenario in this analysis the median overall survival for the blended group, was 17.7 months. With an upper and lower 95% confidence interval’s listed in the post.
This is worst case because this analysis utilize that IMUC Control group survival curves to form the basis but utilized the number of the events previously disclosed by management / principal investigators, in the DC trial.
The hypothesis is however that these patients most of Whom received the vaccine, either initially or at relapse, will actually survive better than the control group of the IMUC Patient cohort.
TC
The visual curves were reported in the prior Messages. Dropbox inactivated the public folders that contained the survival curves. These have been published before on this message board. Some of the other posters may have copied the graphs.
I have the graphs but have been unable to put them on this message board as this board doesn't allow for visuals.
AP
BLENDED Survival Significantly better than standard of care Median survival
I just reviewed my prior survival analysis for this trial with an eye to determine what the Blended results will be. Please review my prior Messages 129619 and 13558 among others.
Please remember that my analysis used the IMUC control arm to form much of the data, and therefore these Median OS parameters herein reported would represent a 'worse case example'.
When I combined the data and obtained the total group Blended Kaplan Curves I obtained the following:
BLENDED DATA (months) KM Survival
Lower Upper
Bound Bound
MEDIAN 95% 95%
17.7 14.9 21.5
Based on Smith on Stocks recent reviews it does indeed appear that the blended results will be significantly higher than the previously reported standard of care medians from the literature.
MY PRIOR DATA and post INFO
NWBO DCVax-L Survival Analysis Models show significant survival benefit
Finally I have finished the Survival Model for the DCVax-L Trial.
Model Parameters:
1. First developed a spreadsheet using the entry ramp published at ASCO 2017 by Bousch MD and NWBO.
2.Assigned in a 2 to 1 ratio the experimental and Placebo groups.
3. Used the IMUC Published ITT survival curves (published at ASCO 2014) to extrapolate to the NWBO dataset. The primary assumption for this model is that the IMUC Control Survival will be essentially equal to the NWBO Control Survival Curve. This is a reasonable assumption as the entry requirements for the IMUC trial and the NWBO trial are very similar.
4 The model for the NWBO control patients data to be equivalent to the IMUC Control Data, requires 87 death events to for the NWBO control group. It was disclosed at ASCO 2017 that there were still 100 Patients alive in the entire NWBO dataset. Therefore, there would be 331-100 or 231 total death events for the entire NWBO dataset. Utilizing the derived 87 death events from the model, one then can ascertain that there would be 144 death events in the DCVax-L treatment group (ie 231-87=144).
5. Armed with this derived number of events (144) in the experimental arm, one can model the experimental arm by modeling the NWBO data using the IMUC Control arm date but limiting the number of death events to only 144.
6. One then can then compare the overall survival KM survival curves for the DCVax-L experimental group (N=221) and the Placebo group (N=110).
When one does this the results show a statistically significant (p=.029) improvement in OS favoring the treatment group with a Median OS of 19 vs 15 months and a 75 Quartile survival not yet obtained by the experimental group.
To visualize the Survival Curve click on this link.
https://dl.dropboxusercontent.com/u/11047753/NWBO%20Survival%20Curve.JPG
Summary statistics (Events):
Stratum Total observed Total failed Total censored Time steps
1 DCVAX-L 221 141 80 164
2 PLACEBO 110 87 23 79
Test of equality of the survival distribution functions (DF = 1):
COMPARISION OF GROUPS
Statistic Observed value Critical value p-value alpha
Log-rank 5.474 3.841 0.019 0.050
Wilcoxon 4.784 3.841 0.029 0.050
Tarone-Ware 5.268 3.841 0.022 0.050
NWBO CONTROL Patients DATA:
Results for 2: PLACEBO
Summary statistics (2):
Total observed Total failed Total censored
110 87 23
Mean survival time (2):
Mean survival NWBO Control time (IMUC Control Mos Fup or death expanded<107.255333333333) Standard deviation Lower bound (95%) Upper bound (95%)
33.998 3.633 26.878 41.119
Quantiles estimation (2):
Quantile Estimate Lower bound (95%) Upper bound (95%)
75% 32.000 19.667
50% 15.167 13.333 17.833
25% 10.600 10.333 12.000
Kaplan-Meier table (2): NWBO CONTROL PATIENTS
IMUC Control Mos Fup or death expanded At risk Failed Censored Proportion failed Survival rate Survival distribution function
6.666667 110 1 0 0.009 0.991 0.991
6.8 109 1 0 0.009 0.991 0.982
7.333333 108 2 0 0.019 0.981 0.964
7.833333 106 1 0 0.009 0.991 0.955
8.333333 105 3 0 0.029 0.971 0.927
8.5 102 2 0 0.020 0.980 0.909
8.533333 100 1 0 0.010 0.990 0.900
8.666667 99 2 0 0.020 0.980 0.882
9.4 97 1 0 0.010 0.990 0.873
10.13333 96 1 0 0.010 0.990 0.864
10.26667 95 3 0 0.032 0.968 0.836
10.3 92 1 0 0.011 0.989 0.827
10.33333 91 1 0 0.011 0.989 0.818
10.4 90 4 0 0.044 0.956 0.782
10.5 86 1 0 0.012 0.988 0.773
10.56667 85 1 0 0.012 0.988 0.764
10.6 84 2 0 0.024 0.976 0.745
10.7 82 1 0 0.012 0.988 0.736
10.8 81 2 0 0.025 0.975 0.718
11 79 1 0 0.013 0.987 0.709
11.33333 78 2 0 0.026 0.974 0.691
11.5 76 1 0 0.013 0.987 0.682
11.66667 75 2 0 0.027 0.973 0.664
12 73 1 0 0.014 0.986 0.655
12.33333 72 1 0 0.014 0.986 0.645
12.85 71 1 0 0.014 0.986 0.636
13.16667 70 2 0 0.029 0.971 0.618
13.25 68 1 0 0.015 0.985 0.609
13.33333 67 2 0 0.030 0.970 0.591
13.38333 65 1 0 0.015 0.985 0.582
13.43333 64 1 0 0.016 0.984 0.573
13.46667 63 1 0 0.016 0.984 0.564
13.5 62 2 0 0.032 0.968 0.545
13.75 60 1 0 0.017 0.983 0.536
14 59 2 0 0.034 0.966 0.518
15 57 2 0 0.035 0.965 0.500
15.16667 55 1 0 0.018 0.982 0.491
15.33333 54 2 0 0.037 0.963 0.473
15.5 52 1 0 0.019 0.981 0.464
15.66667 51 1 0 0.020 0.980 0.455
16.33333 50 1 0 0.020 0.980 0.445
17 49 2 0 0.041 0.959 0.427
17.41667 47 1 0 0.021 0.979 0.418
17.83333 46 2 0 0.043 0.957 0.400
18.33333 44 1 0 0.023 0.977 0.391
18.83333 43 1 0 0.023 0.977 0.382
19.08333 42 1 0 0.024 0.976 0.373
19.33333 41 2 0 0.049 0.951 0.355
19.5 39 1 0 0.026 0.974 0.345
19.66667 38 2 0 0.053 0.947 0.327
21.3 36 0 1
23.33333 35 1 0 0.029 0.971 0.318
23.36667 34 1 0 0.029 0.971 0.309
23.4 33 2 0 0.061 0.939 0.290
23.5 31 1 0 0.032 0.968 0.281
27.66667 30 1 0 0.033 0.967 0.271
32 29 7 0 0.241 0.759 0.206
34 22 0 1
105.1463 21 0 1
105.2573 20 0 1
105.3683 19 0 1
105.4793 18 0 1
105.5903 17 0 1
105.7013 16 0 1
105.8123 15 0 1
105.9233 14 0 1
106.0343 13 0 1
106.1453 12 0 1
106.2563 11 0 1
106.3673 10 0 1
106.4783 9 0 1
106.5893 8 0 1
106.7003 7 0 1
106.8113 6 0 1
106.9223 5 0 1
107.0333 4 0 1
107.1443 3 0 1
107.2553 2 0 1
107.3943 1 0 1
NWBO EXPERIMENTAL DCVaX-L Treatment ARM DATA:
Results for 1:DCVAC-L TREATMENT Experimental Group
Summary statistics (1):
Total observed Total failed Total censored
221 141 80
Mean survival time (1):
Mean survival time (IMUC Control Mos Fup or death expanded<35.6146666666648) Standard deviation Lower bound (95%) Upper bound (95%)
22.236 0.744 20.777 23.695
Quantiles estimation (1):
QuantileEstimate Lower bound (95%) Upper bound (95%)
75%
50% 18.967 15.667 23.400
25% 11.500 10.600 13.250
IMUC Control Mos Fup or death expanded At risk Failed Censored Proportion failed Survival rate Survival distribution function Standard error of the survival function Lower bound (95%) Upper bound (95%)
6.666667 221 1 0 0.005 0.995 0.995 0.005 0.987 1.000
6.8 220 1 0 0.005 0.995 0.991 0.006 0.978 1.000
7 219 1 0 0.005 0.995 0.986 0.008 0.971 1.000
7.333333 218 2 0 0.009 0.991 0.977 0.010 0.958 0.997
7.6 216 1 0 0.005 0.995 0.973 0.011 0.951 0.994
7.833333 215 1 0 0.005 0.995 0.968 0.012 0.945 0.991
8.333333 214 4 0 0.019 0.981 0.950 0.015 0.922 0.979
8.4 210 1 0 0.005 0.995 0.946 0.015 0.916 0.976
8.466667 209 1 0 0.005 0.995 0.941 0.016 0.910 0.972
8.5 208 3 0 0.014 0.986 0.928 0.017 0.893 0.962
8.533333 205 1 0 0.005 0.995 0.923 0.018 0.888 0.958
8.666667 204 3 0 0.015 0.985 0.910 0.019 0.872 0.947
9.4 201 1 0 0.005 0.995 0.905 0.020 0.866 0.944
9.733333 200 1 0 0.005 0.995 0.900 0.020 0.861 0.940
10.13333 199 1 0 0.005 0.995 0.896 0.021 0.856 0.936
10.26667 198 5 0 0.025 0.975 0.873 0.022 0.829 0.917
10.3 193 2 0 0.010 0.990 0.864 0.023 0.819 0.909
10.33333 191 2 0 0.010 0.990 0.855 0.024 0.809 0.902
10.4 189 5 0 0.026 0.974 0.833 0.025 0.783 0.882
10.46667 184 2 0 0.011 0.989 0.824 0.026 0.773 0.874
10.5 182 1 0 0.005 0.995 0.819 0.026 0.768 0.870
10.56667 181 1 0 0.006 0.994 0.814 0.026 0.763 0.866
10.6 180 3 0 0.017 0.983 0.801 0.027 0.748 0.854
10.66667 177 1 0 0.006 0.994 0.796 0.027 0.743 0.849
10.7 176 1 0 0.006 0.994 0.792 0.027 0.738 0.845
10.8 175 3 0 0.017 0.983 0.778 0.028 0.724 0.833
11 172 1 0 0.006 0.994 0.774 0.028 0.719 0.829
11.16667 171 2 0 0.012 0.988 0.765 0.029 0.709 0.821
11.33333 169 2 0 0.012 0.988 0.756 0.029 0.699 0.812
11.43333 167 1 0 0.006 0.994 0.751 0.029 0.694 0.808
11.5 166 1 0 0.006 0.994 0.747 0.029 0.689 0.804
11.66667 165 3 0 0.018 0.982 0.733 0.030 0.675 0.791
12 162 1 0 0.006 0.994 0.729 0.030 0.670 0.787
12.16667 161 1 0 0.006 0.994 0.724 0.030 0.665 0.783
12.3 160 1 0 0.006 0.994 0.719 0.030 0.660 0.779
12.33333 159 1 0 0.006 0.994 0.715 0.030 0.655 0.774
12.85 158 1 0 0.006 0.994 0.710 0.031 0.651 0.770
13 157 2 0 0.013 0.987 0.701 0.031 0.641 0.762
13.16667 155 2 0 0.013 0.987 0.692 0.031 0.631 0.753
13.25 153 1 0 0.007 0.993 0.688 0.031 0.627 0.749
13.33333 152 3 0 0.020 0.980 0.674 0.032 0.612 0.736
13.38333 149 1 0 0.007 0.993 0.670 0.032 0.608 0.732
13.4 148 1 0 0.007 0.993 0.665 0.032 0.603 0.727
13.43333 147 2 0 0.014 0.986 0.656 0.032 0.593 0.719
13.46667 145 2 0 0.014 0.986 0.647 0.032 0.584 0.710
13.5 143 3 0 0.021 0.979 0.633 0.032 0.570 0.697
13.63333 140 1 0 0.007 0.993 0.629 0.032 0.565 0.693
13.75 139 1 0 0.007 0.993 0.624 0.033 0.561 0.688
14 138 3 0 0.022 0.978 0.611 0.033 0.547 0.675
15 135 3 0 0.022 0.978 0.597 0.033 0.533 0.662
15.16667 132 1 0 0.008 0.992 0.593 0.033 0.528 0.658
15.23333 131 1 0 0.008 0.992 0.588 0.033 0.523 0.653
15.26667 130 1 0 0.008 0.992 0.584 0.033 0.519 0.649
15.33333 129 2 0 0.016 0.984 0.575 0.033 0.509 0.640
15.43333 127 1 0 0.008 0.992 0.570 0.033 0.505 0.635
15.5 126 1 0 0.008 0.992 0.566 0.033 0.500 0.631
15.66667 125 1 0 0.008 0.992 0.561 0.033 0.496 0.627
16 124 1 0 0.008 0.992 0.557 0.033 0.491 0.622
16.33333 123 1 0 0.008 0.992 0.552 0.033 0.486 0.618
17 122 3 0 0.025 0.975 0.538 0.034 0.473 0.604
17.41667 119 1 0 0.008 0.992 0.534 0.034 0.468 0.600
17.6 118 1 0 0.008 0.992 0.529 0.034 0.464 0.595
17.76667 117 1 0 0.009 0.991 0.525 0.034 0.459 0.591
17.83333 116 2 0 0.017 0.983 0.516 0.034 0.450 0.582
18.06667 114 1 0 0.009 0.991 0.511 0.034 0.445 0.577
18.33333 113 1 0 0.009 0.991 0.507 0.034 0.441 0.573
18.83333 112 1 0 0.009 0.991 0.502 0.034 0.436 0.568
18.96667 111 1 0 0.009 0.991 0.498 0.034 0.432 0.564
19.08333 110 1 0 0.009 0.991 0.493 0.034 0.427 0.559
19.33333 109 3 0 0.028 0.972 0.480 0.034 0.414 0.546
19.5 106 1 0 0.009 0.991 0.475 0.034 0.409 0.541
19.56667 105 1 0 0.010 0.990 0.471 0.034 0.405 0.536
19.6 104 1 0 0.010 0.990 0.466 0.034 0.400 0.532
19.66667 103 2 0 0.019 0.981 0.457 0.034 0.391 0.523
20.83333 101 0 1
21.6 100 1 0 0.010 0.990 0.452 0.033 0.387 0.518
23.33333 99 1 0 0.010 0.990 0.448 0.033 0.382 0.513
23.36667 98 1 0 0.010 0.990 0.443 0.033 0.378 0.509
23.4 97 3 0 0.031 0.969 0.430 0.033 0.364 0.495
23.46667 94 1 0 0.011 0.989 0.425 0.033 0.360 0.490
23.5 93 1 0 0.011 0.989 0.420 0.033 0.355 0.486
27.06767 92 0 1
27.17867 91 0 1
27.28967 90 0 1
27.40067 89 0 1
27.51167 88 0 1
27.62267 87 0 1
27.66667 86 1 0 0.012 0.988 0.416 0.033 0.350 0.481
27.73367 85 0 1
27.84467 84 0 1
27.95567 83 0 1
28.06667 82 0 1
28.17767 81 0 1
28.28867 80 0 1
28.39967 79 0 1
28.51067 78 0 1
28.62167 77 0 1
28.73267 76 0 1
28.84367 75 0 1
28.95467 74 0 1
29.06567 73 0 1
29.17667 72 0 1
29.28767 71 0 1
29.33333 70 1 0 0.014 0.986 0.410 0.033 0.344 0.475
29.39867 69 0 1
29.50967 68 0 1
29.62067 67 0 1
29.73167 66 0 1
29.84267 65 0 1
29.95367 64 0 1
30.06467 63 0 1
30.17567 62 0 1
30.28667 61 0 1
30.39767 60 0 1
30.50867 59 0 1
30.61967 58 0 1
30.66667 57 1 0 0.018 0.982 0.402 0.033 0.337 0.468
30.73067 56 0 1
30.84167 55 0 1
30.95267 54 0 1
31.06367 53 0 1
31.17467 52 0 1
31.28567 51 0 1
31.39667 50 0 1
31.50767 49 0 1
31.61867 48 0 1
31.72967 47 0 1
31.84067 46 0 1
31.95167 45 0 1
32 44 10 0 0.227 0.773 0.311 0.036 0.240 0.382
32.06267 34 0 1
32.17367 33 0 1
32.28467 32 0 1
32.39567 31 0 1
32.50667 30 0 1
32.61767 29 0 1
32.72867 28 0 1
32.83967 27 0 1
32.95067 26 0 1
33.06167 25 0 1
33.17267 24 0 1
33.28367 23 0 1
33.39467 22 0 1
33.50567 21 0 1
33.61667 20 0 1
33.72767 19 0 1
33.83867 18 0 1
33.94967 17 0 1
34.06067 16 0 1
34.17167 15 0 1
34.28267 14 0 1
34.39367 13 0 1
34.50467 12 0 1
34.61567 11 0 1
34.72667 10 0 1
34.83767 9 0 1
34.94867 8 0 1
35.05967 7 0 1
35.17067 6 0 1
35.28167 5 0 1
35.39267 4 0 1
35.50367 3 0 1
35.61467 2 0 1
35.72567 1 0 1
Discloser
I am long NWBO stock; I am a clinical Researcher
It was probably shingles. Which is common in patients who are receiving chemotherapy. But shingles of the optic nerve can be quite serious.
Actually the talks are in the central nervous system section under challenging CNS cases 2016 WHO update
Go to the 2017 virtual meeting. It should be on the Astro website
Astro.org
Then under meetings and education click on virtual meetings
Then click on the 2017 Astro annual meeting
The talks are then in the section entitled central nervous system and immunotherapy
Click on the immunotherapy one
Go to challenging CNS cases 2016 WHO update
The talk is immunotherapy in the treatment of gliomas by Patrick Wen MD and imaging response in era of immunotherapy by Whitney Pope MD PhD
Hope this helps. I found both to be very informative and positive. We certainly do have Tools Available to be more definitive regarding pseudo-progression. I just hope that the trial has utilize some of these tools so that we get an accurate reading of Progression free survival up in our trial.
The problems with determining progression may be why we are all waiting as the company wants enough time to relapse in order to get positive on overall survival.
Hey just got my virtual meeting packet from last months American society of therapeutic radiology and oncology national conference, (ASTRO)
There are a number of very excellent reviews regarding DCVax. One in particular was from UCLA neuroradiology that had a very nice review on pseudoprogression.
Also they showed a lot of radiographs showing response.
One of the talks showed that an immunotherapy platform using multiple antigens may well be preferable to those platforms that have more limited antigens.
It is moving like a glacier, but more and more data is starting to hit mainstream medical meetings.
If anyone has access to these and can post them that might be very informative for a number of investors.
Hey Petey
I would advise you to keep your limit price higher than 2 in case there is a squeeze that could go up higher than that. This could have the potential to rocket higher.
But Senti
In an offhanded way, LP is the actual seller. Because every time she does a dilutive sale of millions upon millions upon millions, of shares the end result is what we are seeing.
Despite this, I am very optimistic giving my own data and the extensive data of the leprechaun.
Investors however just need to know that this stock cannot not be timed because any time scale for any particular future event that we are given by management, one must multiply that by a factor of 10 or 20. So if the management says such and such will happen in two weeks, one needs to times that by 10 to 20 to get what really likely will transpire in reality.
Thanks leprechaun
I concur with your conclusions. It is really nice to see another method, that independently comes up with the same / similar conclusions as analysis of my own have produced.
AP
YUP
You are correct currently the SOC is TMZ (temazolamide) chemotherapy. I was just pointing out that the DCVax-L does not have the side effects like chemo does.
DCVaX-L is given after the RT + TMZ and during the maintenance phase of every 3 weeks TMZ.
AP
HANK
I previously ran this analysis assuming an August 2015 data lock and still it was significant.
Prior POST.
Jammy
Here is the model with a lock date of 8-15-2015.
Still PFS is significant. I expect however that OS would not be significant at this time.
Note only 313 cases at this time as some participants were randomized after this lock date.
https://www.dropbox.com/s/ml1mpe0q0wt9ue3/dcfax%20PFS%20model%20lock%20date%20aug%202015%20-%20Copy.JPG?dl=0
So it is still significant even if the events occurred earlier.
AP
Thanks Marzan
Great Idea
I will look into it to see how hard it is to put it in the seeking Alpha website.
AP
Thanks for catching that.
HERE IS THE UPDATED link for the overall survival analysis.
https://www.dropbox.com/s/tcpon1ksw0dxi0g/NWBO%20Survival%20Curve.JPG?dl=0
When other posters publish erroneous data about the PFS and OS data just to confuse and attempt to incite fear, I will republish my complete organized, thoughtful and correct analysis. AS I have said previously, I am giving you the reader a look into the future before it is announced.
Worst case analysis Overall Survival
Assumption 1: Recently the company disclosed the trial entry data and indicated that as of 7-15-2017 there were 98 patients out of the 331 randomized, still alive. Utilizing this new data, I endeavored to model a worst-case DCVax-L GBM survival curve for all patients. Since 90% of the patients in this trial have received the experimental treatment DCVax-L, this trial is really a randomization of upfront early use DCVax-L vs Delayed used of DCVAX-L given after the first progression. For the purpose of creating this curve, one assumes that only the 98 most recently randomized in the trial are still alive. Hence this will provide us with the least amount of survival time as all their other patients were randomized at an earlier date. Furthermore, in these remaining patients, we know for a fact the amount of time for follow-up as we have been given there entry randomization date and we have been told that there will be 98 patients still alive by 7-15-2017.
Assumption 2: If you, therefore, assume that all remaining patients randomized early survived by an amount equal to the quoted standard of care (SOC) median survival of 15-17 months, one can generate a Kaplan-Meyer Survival curve for the entire 331 patients which will be the worse case scenario especially for the tail of the survival curve.
When one does this the 36 month tail survival for all patients is equal to nearly 30% . This tail long-term survival is essentially equivalent to what has been reported and published by the Optune dataset.
Please remember that this analysis is intended to return the worse case survival curve because we already know that many of the earlier randomized patients have lived longer than SOC.
THEREFORE this analysis would suggest that the total group of patients in the DCVax-L Trial will have overall survival curves much better than the one shown that has a tail equivalent to what has been published with the OPTUNE dataset.
I wish I could model this more precisely but the limited data points makes that impossible.
It does look like the survival will be quite good in this trial as a whole.
Summary statistics:
Total observed Total failed Total censored
331 233 98
Kaplan-Meier table:
Months At risk Failed Censored Proportion failed
15 331 78 0 0.236
16 253 77 0 0.304
17 176 78 0 0.443
20.26666667 98 0 1
20.507 97 0 1
20.618 96 0 1
20.729 95 0 1
20.73333333 94 0 1
20.84 93 0 1
20.951 92 0 1
21.062 91 0 1
21.173 90 0 1
21.284 89 0 1
21.395 88 0 1
21.506 87 0 1
21.617 86 0 1
21.728 85 0 1
21.839 84 0 1
21.95 83 0 1
22.061 82 0 1
22.172 81 0 1
22.283 80 0 1
22.394 79 0 1
22.505 78 0 1
22.616 77 0 1
22.727 76 0 1
22.838 75 0 1
22.949 74 0 1
23.06 73 0 1
23.171 72 0 1
23.282 71 0 1
23.393 70 0 1
23.504 69 0 1
23.615 68 0 1
23.726 67 0 1
23.837 66 0 1
23.948 65 0 1
24.059 64 0 1
24.17 63 0 1
24.281 62 0 1
24.392 61 0 1
24.503 60 0 1
24.614 59 0 1
24.725 58 0 1
24.836 57 0 1
24.947 56 0 1
25.058 55 0 1
25.169 54 0 1
25.28 53 0 1
25.391 52 0 1
25.502 51 0 1
25.613 50 0 1
25.724 49 0 1
25.835 48 0 1
25.946 47 0 1
26.057 46 0 1
26.168 45 0 1
26.279 44 0 1
26.39 43 0 1
26.501 42 0 1
26.612 41 0 1
26.723 40 0 1
26.834 39 0 1
26.945 38 0 1
27.056 37 0 1
27.167 36 0 1
27.278 35 0 1
27.389 34 0 1
27.5 33 0 1
27.611 32 0 1
27.722 31 0 1
27.833 30 0 1
27.944 29 0 1
28.055 28 0 1
28.166 27 0 1
28.277 26 0 1
28.388 25 0 1
28.499 24 0 1
28.61 23 0 1
28.721 22 0 1
28.832 21 0 1
28.943 20 0 1
29.054 19 0 1
29.165 18 0 1
29.276 17 0 1
29.387 16 0 1
29.498 15 0 1
29.609 14 0 1
29.72 13 0 1
29.831 12 0 1
29.942 11 0 1
30.053 10 0 1
30.164 9 0 1
30.275 8 0 1
30.386 7 0 1
30.497 6 0 1
30.608 5 0 1
30.719 4 0 1
30.83 3 0 1
30.941 2 0 1
31.052 1 0 1
25.6717551
Mean survival time:
Mean survival time (Months<30.940999999996)
Mean survival time (Months<30.940999999996) Standard deviation Lower bound (95%) Upper bound (95%)
20.391 0.375 19.656 21.125
Quantiles estimation:
Quantile Estimate Lower bound (95%) Upper bound (95%)
75%
50% 17.000 16.000 17.000
25% 16.000 15.000
NWBO DCVax-L Survival Analysis Models show significant survival benefit
Finally I have finished the Survival Model for the DCVax-L Trial.
Model Parameters:
1. First developed a spreadsheet using the entry ramp published at ASCO 2017 by Bousch MD and NWBO.
2.Assigned in a 2 to 1 ratio the experimental and Placebo groups.
3. Used the IMUC Published ITT survival curves (published at ASCO 2014) to extrapolate to the NWBO dataset. The primary assumption for this model is that the IMUC Control Survival will be essentially equal to the NWBO Control Survival Curve. This is a reasonable assumption as the entry requirements for the IMUC trial and the NWBO trial are very similar.
4 The model for the NWBO control patients data to be equivalent to the IMUC Control Data, requires 87 death events to for the NWBO control group. It was disclosed at ASCO 2017 that there were still 100 Patients alive in the entire NWBO dataset. Therefore, there would be 331-100 or 231 total death events for the entire NWBO dataset. Utilizing the derived 87 death events from the model, one then can ascertain that there would be 144 death events in the DCVax-L treatment group (ie 231-87=144).
5. Armed with this derived number of events (144) in the experimental arm, one can model the experimental arm by modeling the NWBO data using the IMUC Control arm date but limiting the number of death events to only 144.
6. One then can then compare the overall survival KM survival curves for the DCVax-L experimental group (N=221) and the Placebo group (N=110).
When one does this the results show a statistically significant (p=.029) improvement in OS favoring the treatment group with a Median OS of 19 vs 15 months and a 75 Quartile survival not yet obtained by the experimental group.
To visualize the Survival Curve click on this link.
https://dl.dropboxusercontent.com/u/11047753/NWBO%20Survival%20Curve.JPG
Summary statistics (Events):
Stratum Total observed Total failed Total censored Time steps
1 DCVAX-L 221 141 80 164
2 PLACEBO 110 87 23 79
The PFS will be a positive significant result no doubt. Mathematically it would be very close to impossible to not show the result as listed.
Only I guess if NWBO controls do much much better than IMUC controls did, but hey this is GMB we are talking about and there is essentially no plateau in any prior SOC curves.
I am giving you all a look into the future before it is announced. Not with any inside info but with a smart review of what has already been publically revealed by the company.
Not many people can do these kinds of analysis on survival data.
This is the Truth
REPOST with updated links
Data lock will equal a real date.
ie Say 9-1-2017 or whatever.
Then that date will be used as the "last date of Follow-up or Death" and the KM curves and all statistics will use that date to calculate the time factor (ie amount of time from a patients entry into the trial to the particular parameter measured such as progression or death or whatever is defined as an 'event'. Or if the patient has not experienced any event they will have a time factor = to the lock date minus their date of trial entry and randomization.
For patients that have not evented, they will be censored and not used for making the KM curve for any time that is greater than the difference of the lock date minus their particular data entry date or randomization date.
Please see this review and comparison of my PFS model results with the NEJM STUPP data. One can see how revolutionary this treatment will be as the STUPP protocol is arguably still the standard of Care (+/- Optune).
https://www.dropbox.com/s/ywsv4jyv7mkucxs/DCVacL%20compared%20to%20STUPP.JPG?dl=0
Also, note the Stupp gragh gives the number of patients at risk at various time intervals under the gragh so one knows how many patients data are left for the longer time periods out. IE those numbers below equal the total number of patients on the various trial arms minus those who have evented or who were censored.
For you to better understand this I include below the data I used to create the current model comparisons. So, in this case, the Date of entry is the dates given by Bosch at ASCO 2017 for the patient enrollment ramp. The treatment(1) or Placebo (2) was generated by a random number generator in excel in a 2 to 1 ratio for experimental and placebo respectively. Then the Control (0) group was manually given the time in days and the events directly based on the IMUC Control group data pro rata to compensate for the larger NWBO trial.
Then once the number of events were derived in the NWBO control group by this method, the number of events remaining was simply a subtraction of the number of PFS events that NWBO has given us on 2 separate occasions: Once in Dec 2013 66 PFS events for the whole group and another disclosed in Feb. 2017 or before when 248 events were disclosed.
Then the exact same process was used on the experimental patient group in that the events and time were placed in to be equal to the published IMUC control group KM PFS curves ... but here is the cool part ... the number of events was limited to 148 which was derived as noted above and by Dec 2013 only 66 events were placed prior to that date. Therefore there were significantly fewer events in the experimental DCVaxL arm than would have been expected had the experiment arm survived progression free at the same rate as was published by the IMUC control group curves.
Then it was a simple matter of inputting the time factor, the event/censor factor and the group placebo or experimental into the KM statistical software.
And walla the curves appear with the statistical comparison tests.
Derived Data for all 331 patients in the DCVax-L TRIAL
PT # * ENTRY * RX=1 Placebo=0 * DAYS * 1=event 0= censor * DATE EVENT or Censor * MONTHS * Plus 83d Mo
1 * 6/2/2008 * 1 * 53 * 1 * 7/25/2008 * 1.8 * 4.6
2 * 6/13/2008 * 0 * 53 * 1 * 8/5/2008 * 1.8 * 4.6
3 * 6/27/2008 * 1 * 53 * 1 * 8/19/2008 * 1.8 * 4.6
4 * 7/23/2008 * 0 * 53 * 1 * 9/14/2008 * 1.8 * 4.6
5 * 7/10/2008 * 1 * 85 * 1 * 10/3/2008 * 2.8 * 5.6
6 * 8/5/2008 * 0 * 85 * 1 * 10/29/2008 * 2.8 * 5.6
7 * 9/12/2008 * 1 * 85 * 1 * 12/6/2008 * 2.8 * 5.6
8 * 9/26/2008 * 1 * 95 * 1 * 12/30/2008 * 3.2 * 6
9 * 10/9/2008 * 1 * 95 * 1 * 1/12/2009 * 3.2 * 6
10 * 11/4/2008 * 0 * 85 * 1 * 1/28/2009 * 2.8 * 5.6
11 * 11/17/2008 * 0 * 95 * 1 * 2/20/2009 * 3.2 * 6
12 * 12/1/2008 * 0 * 95 * 1 * 3/6/2009 * 3.2 * 6
13 * 12/12/2008 * 0 * 105 * 1 * 3/27/2009 * 3.5 * 6.3
14 * 12/26/2008 * 0 * 105 * 1 * 4/10/2009 * 3.5 * 6.3
15 * 1/8/2009 * 0 * 112 * 1 * 4/30/2009 * 3.7 * 6.5
16 * 2/3/2009 * 1 * 105 * 1 * 5/19/2009 * 3.5 * 6.3
17 * 2/16/2009 * 1 * 105 * 1 * 6/1/2009 * 3.5 * 6.3
18 * 3/2/2009 * 0 * 112 * 1 * 6/22/2009 * 3.7 * 6.5
19 * 3/13/2009 * 0 * 112 * 1 * 7/3/2009 * 3.7 * 6.5
20 * 3/27/2009 * 0 * 112 * 1 * 7/17/2009 * 3.7 * 6.5
21 * 4/9/2009 * 1 * 112 * 1 * 7/30/2009 * 3.7 * 6.5
22 * 10/3/2011 * 0 * 120 * 1 * 1/31/2012 * 4 * 6.8
23 * 10/21/2011 * 0 * 120 * 1 * 2/18/2012 * 4 * 6.8
24 * 11/2/2011 * 0 * 120 * 1 * 3/1/2012 * 4 * 6.8
25 * 11/14/2011 * 1 * 112 * 1 * 3/5/2012 * 3.7 * 6.5
26 * 11/24/2011 * 0 * 120 * 1 * 3/23/2012 * 4 * 6.8
27 * 12/5/2011 * 0 * 120 * 1 * 4/3/2012 * 4 * 6.8
28 * 12/15/2011 * 1 * 112 * 1 * 4/5/2012 * 3.7 * 6.5
29 * 12/26/2011 * 1 * 112 * 1 * 4/16/2012 * 3.7 * 6.5
30 * 1/6/2012 * 0 * 120 * 1 * 5/5/2012 * 4 * 6.8
31 * 2/7/2012 * 0 * 122 * 1 * 6/8/2012 * 4.1 * 6.9
32 * 2/17/2012 * 1 * 120 * 1 * 6/16/2012 * 4 * 6.8
33 * 2/29/2012 * 0 * 122 * 1 * 6/30/2012 * 4.1 * 6.9
34 * 3/11/2012 * 1 * 120 * 1 * 7/9/2012 * 4 * 6.8
35 * 3/21/2012 * 1 * 120 * 1 * 7/19/2012 * 4 * 6.8
36 * 4/1/2012 * 0 * 123 * 1 * 8/2/2012 * 4.1 * 6.9
37 * 5/4/2012 * 0 * 123 * 1 * 9/4/2012 * 4.1 * 6.9
38 * 5/14/2012 * 1 * 120 * 1 * 9/11/2012 * 4 * 6.8
39 * 5/25/2012 * 1 * 120 * 1 * 9/22/2012 * 4 * 6.8
40 * 6/5/2012 * 0 * 126 * 1 * 10/9/2012 * 4.2 * 7
41 * 6/16/2012 * 1 * 120 * 1 * 10/14/2012 * 4 * 6.8
42 * 6/27/2012 * 0 * 126 * 1 * 10/31/2012 * 4.2 * 7
43 * 8/20/2012 * 1 * 122 * 1 * 12/20/2012 * 4.1 * 6.9
44 * 7/29/2012 * 0 * 151 * 1 * 12/27/2012 * 5 * 7.8
45 * 8/9/2012 * 0 * 151 * 1 * 1/7/2013 * 5 * 7.8
46 * 9/10/2012 * 1 * 122 * 1 * 1/10/2013 * 4.1 * 6.9
47 * 9/21/2012 * 1 * 123 * 1 * 1/22/2013 * 4.1 * 6.9
48 * 8/30/2012 * 0 * 158 * 1 * 2/4/2013 * 5.3 * 8.1
49 * 11/3/2012 * 1 * 123 * 1 * 3/6/2013 * 4.1 * 6.9
50 * 11/14/2012 * 1 * 126 * 1 * 3/20/2013 * 4.2 * 7
51 * 10/23/2012 * 0 * 158 * 1 * 3/30/2013 * 5.3 * 8.1
52 * 12/16/2012 * 1 * 126 * 1 * 4/21/2013 * 4.2 * 7
53 * 11/25/2012 * 0 * 158 * 1 * 5/2/2013 * 5.3 * 8.1
54 * 12/6/2012 * 0 * 172 * 1 * 5/27/2013 * 5.7 * 8.5
55 * 1/18/2013 * 1 * 151 * 1 * 6/18/2013 * 5 * 7.8
56 * 1/29/2013 * 1 * 151 * 1 * 6/29/2013 * 5 * 7.8
57 * 2/8/2013 * 1 * 158 * 1 * 7/16/2013 * 5.3 * 8.1
58 * 2/19/2013 * 0 * 172 * 1 * 8/10/2013 * 5.7 * 8.5
59 * 3/2/2013 * 0 * 172 * 1 * 8/21/2013 * 5.7 * 8.5
60 * 4/3/2013 * 1 * 158 * 1 * 9/8/2013 * 5.3 * 8.1
61 * 4/25/2013 * 1 * 158 * 1 * 9/30/2013 * 5.3 * 8.1
62 * 4/14/2013 * 0 * 175 * 1 * 10/6/2013 * 5.8 * 8.6
63 * 5/6/2013 * 0 * 175 * 1 * 10/28/2013 * 5.8 * 8.6
64 * 5/15/2013 * 0 * 182 * 1 * 11/13/2013 * 6.1 * 8.9
65 * 5/30/2013 * 1 * 172 * 1 * 11/18/2013 * 5.7 * 8.5
66 * 5/26/2013 * 0 * 182 * 1 * 11/24/2013 * 6.1 * 8.9
67 * 6/13/2013 * 1 * 172 * 1 * 12/2/2013 * 5.7 * 8.5
68 * 6/17/2013 * 1 * 172 * 1 * 12/6/2013 * 5.7 * 8.5
69 * 6/22/2013 * 1 * 175 * 1 * 12/14/2013 * 5.8 * 8.6
70 * 7/5/2013 * 1 * 175 * 1 * 12/27/2013 * 5.8 * 8.6
71 * 7/14/2013 * 1 * 182 * 1 * 1/12/2014 * 6.1 * 8.9
72 * 7/19/2013 * 1 * 182 * 1 * 1/17/2014 * 6.1 * 8.9
73 * 7/10/2013 * 0 * 200 * 1 * 1/26/2014 * 6.7 * 9.5
74 * 7/23/2013 * 0 * 200 * 1 * 2/8/2014 * 6.7 * 9.5
75 * 8/6/2013 * 1 * 200 * 1 * 2/22/2014 * 6.7 * 9.5
76 * 8/15/2013 * 1 * 200 * 1 * 3/3/2014 * 6.7 * 9.5
77 * 8/10/2013 * 0 * 206 * 1 * 3/4/2014 * 6.9 * 9.7
78 * 8/19/2013 * 1 * 206 * 1 * 3/13/2014 * 6.9 * 9.7
79 * 9/2/2013 * 1 * 206 * 1 * 3/27/2014 * 6.9 * 9.7
80 * 9/7/2013 * 0 * 206 * 1 * 4/1/2014 * 6.9 * 9.7
81 * 9/11/2013 * 1 * 210 * 1 * 4/9/2014 * 7 * 9.8
82 * 9/16/2013 * 1 * 210 * 1 * 4/14/2014 * 7 * 9.8
83 * 9/20/2013 * 0 * 210 * 1 * 4/18/2014 * 7 * 9.8
84 * 10/13/2013 * 0 * 210 * 1 * 5/11/2014 * 7 * 9.8
85 * 10/4/2013 * 1 * 224 * 1 * 5/16/2014 * 7.5 * 10.3
86 * 10/8/2013 * 1 * 224 * 1 * 5/20/2014 * 7.5 * 10.3
87 * 10/17/2013 * 0 * 224 * 1 * 5/29/2014 * 7.5 * 10.3
88 * 10/22/2013 * 0 * 224 * 1 * 6/3/2014 * 7.5 * 10.3
89 * 10/26/2013 * 1 * 260 * 1 * 7/13/2014 * 8.7 * 11.5
90 * 11/9/2013 * 1 * 260 * 1 * 7/27/2014 * 8.7 * 11.5
91 * 11/13/2013 * 1 * 278 * 1 * 8/18/2014 * 9.3 * 12.1
92 * 11/18/2013 * 1 * 278 * 1 * 8/23/2014 * 9.3 * 12.1
93 * 12/15/2013 * 0 * 260 * 1 * 9/1/2014 * 8.7 * 11.5
94 * 12/2/2013 * 1 * 290 * 1 * 9/18/2014 * 9.7 * 12.5
95 * 4/21/2014 * 1 * 151 * 1 * 9/19/2014 * 5 * 7.8
96 * 12/6/2013 * 1 * 290 * 1 * 9/22/2014 * 9.7 * 12.5
97 * 12/11/2013 * 1 * 300 * 1 * 10/7/2014 * 10 * 12.8
98 * 1/20/2014 * 0 * 260 * 1 * 10/7/2014 * 8.7 * 11.5
99 * 5/4/2014 * 1 * 158 * 1 * 10/9/2014 * 5.3 * 8.1
100 * 5/13/2014 * 1 * 158 * 1 * 10/18/2014 * 5.3 * 8.1
101 * 8/31/2014 * 1 * 53 * 1 * 10/23/2014 * 1.8 * 4.6
102 * 9/3/2014 * 1 * 53 * 1 * 10/26/2014 * 1.8 * 4.6
103 * 1/25/2014 * 0 * 278 * 1 * 10/30/2014 * 9.3 * 12.1
104 * 12/29/2013 * 1 * 312 * 1 * 11/6/2014 * 10.4 * 13.2
105 * 5/18/2014 * 1 * 172 * 1 * 11/6/2014 * 5.7 * 8.5
106 * 1/2/2014 * 1 * 315 * 1 * 11/13/2014 * 10.5 * 13.3
107 * 6/1/2014 * 1 * 172 * 1 * 11/20/2014 * 5.7 * 8.5
108 * 1/7/2014 * 1 * 318 * 1 * 11/21/2014 * 10.6 * 13.4
109 * 6/6/2014 * 1 * 175 * 1 * 11/28/2014 * 5.8 * 8.6
110 * 3/2/2014 * 0 * 278 * 1 * 12/5/2014 * 9.3 * 12.1
111 * 9/12/2014 * 1 * 85 * 1 * 12/6/2014 * 2.8 * 5.6
112 * 6/18/2014 * 1 * 182 * 1 * 12/17/2014 * 6.1 * 8.9
113 * 1/29/2014 * 1 * 322 * 1 * 12/17/2014 * 10.7 * 13.5
114 * 2/3/2014 * 1 * 321 * 1 * 12/21/2014 * 10.7 * 13.5
115 * 2/7/2014 * 1 * 323 * 1 * 12/27/2014 * 10.8 * 13.6
116 * 9/24/2014 * 1 * 95 * 1 * 12/28/2014 * 3.2 * 6
117 * 3/16/2014 * 0 * 290 * 1 * 12/31/2014 * 9.7 * 12.5
118 * 3/25/2014 * 0 * 290 * 1 * 1/9/2015 * 9.7 * 12.5
119 * 2/21/2014 * 1 * 324 * 1 * 1/11/2015 * 10.8 * 13.6
120 * 2/25/2014 * 1 * 323 * 1 * 1/14/2015 * 10.8 * 13.6
121 * 10/2/2014 * 1 * 105 * 1 * 1/15/2015 * 3.5 * 6.3
122 * 10/5/2014 * 1 * 105 * 1 * 1/18/2015 * 3.5 * 6.3
123 * 3/7/2014 * 1 * 320 * 1 * 1/21/2015 * 10.7 * 13.5
124 * 10/11/2014 * 1 * 112 * 1 * 1/31/2015 * 3.7 * 6.5
125 * 4/12/2014 * 0 * 300 * 1 * 2/6/2015 * 10 * 12.8
126 * 3/29/2014 * 1 * 325 * 1 * 2/17/2015 * 10.8 * 13.6
127 * 4/3/2014 * 1 * 325 * 1 * 2/22/2015 * 10.8 * 13.6
128 * 4/30/2014 * 0 * 300 * 1 * 2/24/2015 * 10 * 12.8
129 * 11/4/2014 * 1 * 112 * 1 * 2/24/2015 * 3.7 * 6.5
130 * 4/7/2014 * 1 * 325 * 1 * 2/26/2015 * 10.8 * 13.6
131 * 11/7/2014 * 1 * 120 * 1 * 3/7/2015 * 4 * 6.8
132 * 11/13/2014 * 1 * 120 * 1 * 3/13/2015 * 4 * 6.8
133 * 5/9/2014 * 0 * 310 * 1 * 3/15/2015 * 10.3 * 13.1
134 * 11/25/2014 * 1 * 120 * 1 * 3/25/2015 * 4 * 6.8
135 * 10/26/2014 * 0 * 151 * 1 * 3/26/2015 * 5 * 7.8
136 * 10/29/2014 * 0 * 151 * 1 * 3/29/2015 * 5 * 7.8
137 * 5/22/2014 * 0 * 312 * 1 * 3/30/2015 * 10.4 * 13.2
138 * 12/3/2014 * 1 * 120 * 1 * 4/2/2015 * 4 * 6.8
139 * 12/6/2014 * 1 * 122 * 1 * 4/7/2015 * 4.1 * 6.9
140 * 11/1/2014 * 0 * 158 * 1 * 4/8/2015 * 5.3 * 8.1
141 * 12/9/2014 * 1 * 122 * 1 * 4/10/2015 * 4.1 * 6.9
142 * 11/10/2014 * 0 * 158 * 1 * 4/17/2015 * 5.3 * 8.1
143 * 12/18/2014 * 1 * 123 * 1 * 4/20/2015 * 4.1 * 6.9
144 * 6/9/2014 * 0 * 315 * 1 * 4/20/2015 * 10.5 * 13.3
145 * 11/19/2014 * 0 * 158 * 1 * 4/26/2015 * 5.3 * 8.1
146 * 6/12/2014 * 0 * 318 * 1 * 4/26/2015 * 10.6 * 13.4
147 * 6/15/2014 * 0 * 319 * 1 * 4/30/2015 * 10.6 * 13.4
148 * 12/27/2014 * 1 * 126 * 1 * 5/2/2015 * 4.2 * 7
149 * 11/22/2014 * 0 * 172 * 1 * 5/13/2015 * 5.7 * 8.5
150 * 12/1/2014 * 0 * 172 * 1 * 5/22/2015 * 5.7 * 8.5
151 * 7/6/2014 * 0 * 320 * 1 * 5/22/2015 * 10.7 * 13.5
152 * 12/30/2014 * 1 * 151 * 1 * 5/30/2015 * 5 * 7.8
153 * 7/15/2014 * 0 * 322 * 1 * 6/2/2015 * 10.7 * 13.5
154 * 1/5/2015 * 1 * 151 * 1 * 6/5/2015 * 5 * 7.8
155 * 12/15/2014 * 0 * 172 * 1 * 6/5/2015 * 5.7 * 8.5
156 * 7/24/2014 * 0 * 321 * 1 * 6/10/2015 * 10.7 * 13.5
157 * 7/27/2014 * 0 * 323 * 1 * 6/15/2015 * 10.8 * 13.6
158 * 12/24/2014 * 0 * 175 * 1 * 6/17/2015 * 5.8 * 8.6
159 * 1/14/2015 * 1 * 158 * 1 * 6/21/2015 * 5.3 * 8.1
160 * 1/2/2015 * 0 * 175 * 1 * 6/26/2015 * 5.8 * 8.6
161 * 6/21/2014 * 1 * 380 * 1 * 7/6/2015 * 12.7 * 15.5
162 * 1/8/2015 * 0 * 182 * 1 * 7/9/2015 * 6.1 * 8.9
163 * 6/27/2014 * 1 * 380 * 1 * 7/12/2015 * 12.7 * 15.5
164 * 1/26/2015 * 1 * 172 * 1 * 7/17/2015 * 5.7 * 8.5
165 * 8/28/2014 * 0 * 324 * 1 * 7/18/2015 * 10.8 * 13.6
166 * 1/29/2015 * 1 * 172 * 1 * 7/20/2015 * 5.7 * 8.5
167 * 2/1/2015 * 1 * 172 * 1 * 7/23/2015 * 5.7 * 8.5
168 * 9/6/2014 * 0 * 324 * 1 * 7/27/2015 * 10.8 * 13.6
169 * 7/3/2014 * 1 * 390 * 1 * 7/28/2015 * 13 * 15.8
170 * 9/18/2014 * 0 * 320 * 1 * 8/4/2015 * 10.7 * 13.5
171 * 9/15/2014 * 0 * 323 * 1 * 8/4/2015 * 10.8 * 13.6
172 * 2/13/2015 * 1 * 175 * 1 * 8/7/2015 * 5.8 * 8.6
173 * 9/27/2014 * 0 * 320 * 1 * 8/13/2015 * 10.7 * 13.5
174 * 9/30/2014 * 0 * 325 * 1 * 8/21/2015 * 10.8 * 13.6
175 * 2/25/2015 * 1 * 182 * 1 * 8/26/2015 * 6.1 * 8.9
176 * 10/17/2014 * 0 * 325 * 1 * 9/7/2015 * 10.8 * 13.6
177 * 10/20/2014 * 0 * 325 * 1 * 9/10/2015 * 10.8 * 13.6
178 * 7/9/2014 * 1 * 430 * 1 * 9/12/2015 * 14.3 * 17.1
179 * 10/23/2014 * 0 * 325 * 1 * 9/13/2015 * 10.8 * 13.6
180 * 7/12/2014 * 1 * 430 * 1 * 9/15/2015 * 14.3 * 17.1
181 * 3/3/2015 * 1 * 200 * 1 * 9/19/2015 * 6.7 * 9.5
182 * 3/6/2015 * 1 * 200 * 1 * 9/22/2015 * 6.7 * 9.5
183 * 7/21/2014 * 1 * 435 * 1 * 9/29/2015 * 14.5 * 17.3
184 * 3/15/2015 * 1 * 206 * 1 * 10/7/2015 * 6.9 * 9.7
185 * 8/1/2014 * 1 * 440 * 1 * 10/15/2015 * 14.7 * 17.5
186 * 3/21/2015 * 1 * 210 * 1 * 10/17/2015 * 7 * 9.8
187 * 3/24/2015 * 1 * 224 * 1 * 11/3/2015 * 7.5 * 10.3
188 * 3/27/2015 * 1 * 224 * 1 * 11/6/2015 * 7.5 * 10.3
189 * 8/4/2014 * 1 * 470 * 1 * 11/17/2015 * 15.7 * 18.5
190 * 8/7/2014 * 1 * 470 * 1 * 11/20/2015 * 15.7 * 18.5
191 * 8/16/2014 * 1 * 480 * 1 * 12/9/2015 * 16 * 18.8
192 * 4/8/2015 * 1 * 260 * 1 * 12/24/2015 * 8.7 * 11.5
193 * 7/28/2015 * 1 * 151 * 1 * 12/26/2015 * 5 * 7.8
194 * 8/3/2015 * 1 * 158 * 1 * 1/8/2016 * 5.3 * 8.1
195 * 8/9/2015 * 1 * 158 * 1 * 1/14/2016 * 5.3 * 8.1
196 * 4/17/2015 * 1 * 278 * 1 * 1/20/2016 * 9.3 * 12.1
197 * 8/19/2014 * 1 * 520 * 1 * 1/21/2016 * 17.3 * 20.1
198 * 1/20/2015 * 0 * 380 * 1 * 2/4/2016 * 12.7 * 15.5
199 * 4/23/2015 * 1 * 290 * 1 * 2/7/2016 * 9.7 * 12.5
200 * 1/23/2015 * 0 * 380 * 1 * 2/7/2016 * 12.7 * 15.5
201 * 4/26/2015 * 1 * 290 * 1 * 2/10/2016 * 9.7 * 12.5
202 * 2/7/2015 * 0 * 380 * 1 * 2/22/2016 * 12.7 * 15.5
203 * 5/2/2015 * 1 * 300 * 1 * 2/26/2016 * 10 * 12.8
204 * 2/10/2015 * 0 * 390 * 1 * 3/6/2016 * 13 * 15.8
205 * 2/16/2015 * 0 * 390 * 1 * 3/12/2016 * 13 * 15.8
206 * 5/8/2015 * 1 * 312 * 1 * 3/15/2016 * 10.4 * 13.2
207 * 5/11/2015 * 1 * 315 * 1 * 3/21/2016 * 10.5 * 13.3
208 * 5/14/2015 * 1 * 318 * 1 * 3/27/2016 * 10.6 * 13.4
209 * 5/26/2015 * 1 * 320 * 1 * 4/10/2016 * 10.7 * 13.5
210 * 6/7/2015 * 1 * 321 * 1 * 4/23/2016 * 10.7 * 13.5
211 * 2/19/2015 * 0 * 430 * 1 * 4/24/2016 * 14.3 * 17.1
212 * 2/28/2015 * 0 * 430 * 1 * 5/3/2016 * 14.3 * 17.1
213 * 6/16/2015 * 1 * 324 * 1 * 5/5/2016 * 10.8 * 13.6
214 * 6/22/2015 * 1 * 324 * 1 * 5/11/2016 * 10.8 * 13.6
215 * 6/28/2015 * 1 * 320 * 1 * 5/13/2016 * 10.7 * 13.5
216 * 3/9/2015 * 0 * 435 * 1 * 5/17/2016 * 14.5 * 17.3
217 * 7/13/2015 * 1 * 325 * 1 * 6/2/2016 * 10.8 * 13.6
218 * 7/16/2015 * 1 * 325 * 1 * 6/5/2016 * 10.8 * 13.6
219 * 3/30/2015 * 0 * 435 * 1 * 6/7/2016 * 14.5 * 17.3
220 * 7/19/2015 * 1 * 325 * 1 * 6/8/2016 * 10.8 * 13.6
221 * 4/2/2015 * 0 * 440 * 1 * 6/15/2016 * 14.7 * 17.5
222 * 4/14/2015 * 0 * 440 * 1 * 6/27/2016 * 14.7 * 17.5
223 * 4/20/2015 * 0 * 470 * 1 * 8/2/2016 * 15.7 * 18.5
224 * 8/12/2015 * 1 * 380 * 1 * 8/26/2016 * 12.7 * 15.5
225 * 5/17/2015 * 0 * 470 * 1 * 8/29/2016 * 15.7 * 18.5
226 * 8/25/2014 * 1 * 740 * 1 * 9/3/2016 * 24.7 * 27.5
227 * 5/23/2015 * 0 * 480 * 1 * 9/14/2016 * 16 * 18.8
228 * 8/24/2015 * 1 * 390 * 1 * 9/17/2016 * 13 * 15.8
229 * 5/29/2015 * 0 * 480 * 1 * 9/20/2016 * 16 * 18.8
230 * 8/27/2015 * 1 * 390 * 1 * 9/20/2016 * 13 * 15.8
231 * 6/1/2015 * 0 * 520 * 1 * 11/2/2016 * 17.3 * 20.1
232 * 8/30/2015 * 1 * 430 * 1 * 11/2/2016 * 14.3 * 17.1
233 * 9/5/2015 * 1 * 435 * 1 * 11/13/2016 * 14.5 * 17.3
234 * 9/11/2015 * 1 * 440 * 1 * 11/24/2016 * 14.7 * 17.5
235 * 9/14/2015 * 1 * 440 * 1 * 11/27/2016 * 14.7 * 17.5
236 * 9/17/2015 * 1 * 470 * 1 * 12/30/2016 * 15.7 * 18.5
237 * 9/29/2015 * 1 * 480 * 1 * 1/21/2017 * 16 * 18.8
238 * 8/13/2014 * 0 * 902.2048193 * 1 * 2/1/2017 * 30.1 * 32.9
239 * 10/5/2015 * 0 * 485 * 0 * 2/1/2017 * 16.2 * 19
240 * 9/23/2015 * 0 * 497 * 0 * 2/1/2017 * 16.6 * 19.4
241 * 9/20/2015 * 0 * 500 * 0 * 2/1/2017 * 16.7 * 19.5
242 * 8/21/2015 * 0 * 530 * 0 * 2/1/2017 * 17.7 * 20.5
243 * 8/18/2015 * 0 * 533 * 0 * 2/1/2017 * 17.8 * 20.6
244 * 8/6/2015 * 0 * 545 * 0 * 2/1/2017 * 18.2 * 21
245 * 7/22/2015 * 0 * 560 * 0 * 2/1/2017 * 18.7 * 21.5
246 * 7/10/2015 * 0 * 572 * 0 * 2/1/2017 * 19.1 * 21.9
247 * 7/7/2015 * 0 * 575 * 0 * 2/1/2017 * 19.2 * 22
248 * 7/4/2015 * 0 * 578 * 0 * 2/1/2017 * 19.3 * 22.1
249 * 6/19/2015 * 0 * 593 * 0 * 2/1/2017 * 19.8 * 22.6
250 * 6/4/2013 * 1 * 1337.95122 * 1 * 2/1/2017 * 44.6 * 47.4
251 * 6/3/2014 * 1 * 973.0481928 * 1 * 2/1/2017 * 32.4 * 35.2
252 * 11/16/2014 * 1 * 807.746988 * 1 * 2/1/2017 * 26.9 * 29.7
253 * 2/22/2015 * 1 * 710 * 1 * 2/1/2017 * 23.7 * 26.5
254 * 4/11/2015 * 1 * 662 * 1 * 2/1/2017 * 22.1 * 24.9
255 * 7/25/2015 * 1 * 557 * 1 * 2/1/2017 * 18.6 * 21.4
256 * 10/2/2015 * 1 * 488 * 1 * 2/1/2017 * 16.3 * 19.1
257 * 8/18/2008 * 1 * 3089 * 0 * 2/1/2017 * 103 * 105.8
258 * 9/1/2008 * 1 * 3075 * 0 * 2/1/2017 * 102.5 * 105.3
259 * 10/22/2008 * 1 * 3024 * 0 * 2/1/2017 * 100.8 * 103.6
260 * 1/21/2009 * 1 * 2933 * 0 * 2/1/2017 * 97.8 * 100.6
261 * 4/15/2009 * 1 * 2849 * 0 * 2/1/2017 * 95 * 97.8
262 * 10/11/2011 * 1 * 1939.2 * 0 * 2/1/2017 * 64.6 * 67.4
263 * 1/17/2012 * 1 * 1842 * 0 * 2/1/2017 * 61.4 * 64.2
264 * 1/27/2012 * 1 * 1831.2 * 0 * 2/1/2017 * 61 * 63.8
265 * 4/12/2012 * 1 * 1755.6 * 0 * 2/1/2017 * 58.5 * 61.3
266 * 4/23/2012 * 1 * 1744.8 * 0 * 2/1/2017 * 58.2 * 61
267 * 7/7/2012 * 1 * 1669.2 * 0 * 2/1/2017 * 55.6 * 58.4
268 * 7/18/2012 * 1 * 1658.4 * 0 * 2/1/2017 * 55.3 * 58.1
269 * 10/2/2012 * 1 * 1582.8 * 0 * 2/1/2017 * 52.8 * 55.6
270 * 10/13/2012 * 1 * 1572 * 0 * 2/1/2017 * 52.4 * 55.2
271 * 12/27/2012 * 1 * 1496.4 * 0 * 2/1/2017 * 49.9 * 52.7
272 * 1/7/2013 * 1 * 1485.6 * 0 * 2/1/2017 * 49.5 * 52.3
273 * 3/13/2013 * 1 * 1420.8 * 0 * 2/1/2017 * 47.4 * 50.2
274 * 3/24/2013 * 1 * 1410 * 0 * 2/1/2017 * 47 * 49.8
275 * 6/8/2013 * 1 * 1333.426829 * 0 * 2/1/2017 * 44.4 * 47.2
276 * 6/26/2013 * 1 * 1315.329268 * 0 * 2/1/2017 * 43.8 * 46.6
277 * 7/1/2013 * 1 * 1310.804878 * 0 * 2/1/2017 * 43.7 * 46.5
278 * 7/28/2013 * 1 * 1283.658537 * 0 * 2/1/2017 * 42.8 * 45.6
279 * 8/1/2013 * 1 * 1279.134146 * 0 * 2/1/2017 * 42.6 * 45.4
280 * 8/24/2013 * 1 * 1256.512195 * 0 * 2/1/2017 * 41.9 * 44.7
281 * 8/29/2013 * 1 * 1251.987805 * 0 * 2/1/2017 * 41.7 * 44.5
282 * 9/25/2013 * 1 * 1224.841463 * 0 * 2/1/2017 * 40.8 * 43.6
283 * 9/29/2013 * 1 * 1220.317073 * 0 * 2/1/2017 * 40.7 * 43.5
284 * 10/31/2013 * 1 * 1188.646341 * 0 * 2/1/2017 * 39.6 * 42.4
285 * 11/4/2013 * 1 * 1184.121951 * 0 * 2/1/2017 * 39.5 * 42.3
286 * 11/22/2013 * 1 * 1166.02439 * 0 * 2/1/2017 * 38.9 * 41.7
287 * 11/27/2013 * 1 * 1161.5 * 0 * 2/1/2017 * 38.7 * 41.5
288 * 12/20/2013 * 1 * 1138.878049 * 0 * 2/1/2017 * 38 * 40.8
289 * 12/24/2013 * 1 * 1134.353659 * 0 * 2/1/2017 * 37.8 * 40.6
290 * 1/11/2014 * 1 * 1116.256098 * 0 * 2/1/2017 * 37.2 * 40
291 * 1/16/2014 * 1 * 1111.731707 * 0 * 2/1/2017 * 37.1 * 39.9
292 * 2/12/2014 * 1 * 1084.585366 * 0 * 2/1/2017 * 36.2 * 39
293 * 2/16/2014 * 1 * 1080.060976 * 0 * 2/1/2017 * 36 * 38.8
294 * 3/11/2014 * 1 * 1057.439024 * 0 * 2/1/2017 * 35.2 * 38
295 * 3/20/2014 * 1 * 1048.390244 * 0 * 2/1/2017 * 34.9 * 37.7
296 * 4/16/2014 * 1 * 1021.243902 * 0 * 2/1/2017 * 34 * 36.8
297 * 4/25/2014 * 1 * 1012.195122 * 0 * 2/1/2017 * 33.7 * 36.5
298 * 5/27/2014 * 1 * 980.5243902 * 0 * 2/1/2017 * 32.7 * 35.5
299 * 6/24/2014 * 1 * 952.3855422 * 0 * 2/1/2017 * 31.7 * 34.5
300 * 6/30/2014 * 1 * 946.4819277 * 0 * 2/1/2017 * 31.5 * 34.3
301 * 7/18/2014 * 1 * 928.7710843 * 0 * 2/1/2017 * 31 * 33.8
302 * 7/30/2014 * 1 * 916.9638554 * 0 * 2/1/2017 * 30.6 * 33.4
303 * 8/10/2014 * 1 * 905.1566265 * 0 * 2/1/2017 * 30.2 * 33
304 * 8/22/2014 * 1 * 893.3493976 * 0 * 2/1/2017 * 29.8 * 32.6
305 * 9/9/2014 * 1 * 875.6385542 * 0 * 2/1/2017 * 29.2 * 32
306 * 9/21/2014 * 1 * 863.8313253 * 0 * 2/1/2017 * 28.8 * 31.6
307 * 10/8/2014 * 1 * 846.1204819 * 0 * 2/1/2017 * 28.2 * 31
308 * 10/14/2014 * 1 * 840.2168675 * 0 * 2/1/2017 * 28 * 30.8
309 * 11/28/2014 * 1 * 795.939759 * 0 * 2/1/2017 * 26.5 * 29.3
310 * 12/12/2014 * 1 * 781.1807229 * 0 * 2/1/2017 * 26 * 28.8
311 * 12/21/2014 * 1 * 772.3253012 * 0 * 2/1/2017 * 25.7 * 28.5
312 * 1/11/2015 * 1 * 751.6626506 * 0 * 2/1/2017 * 25.1 * 27.9
313 * 1/17/2015 * 1 * 745.7590361 * 0 * 2/1/2017 * 24.9 * 27.7
314 * 2/4/2015 * 1 * 728 * 0 * 2/1/2017 * 24.3 * 27.1
315 * 3/12/2015 * 1 * 692 * 0 * 2/1/2017 * 23.1 * 25.9
316 * 3/18/2015 * 1 * 686 * 0 * 2/1/2017 * 22.9 * 25.7
317 * 4/5/2015 * 1 * 668 * 0 * 2/1/2017 * 22.3 * 25.1
318 * 4/29/2015 * 1 * 644 * 0 * 2/1/2017 * 21.5 * 24.3
319 * 5/5/2015 * 1 * 638 * 0 * 2/1/2017 * 21.3 * 24.1
320 * 5/20/2015 * 1 * 623 * 0 * 2/1/2017 * 20.8 * 23.6
321 * 6/4/2015 * 1 * 608 * 0 * 2/1/2017 * 20.3 * 23.1
322 * 6/25/2015 * 1 * 587 * 0 * 2/1/2017 * 19.6 * 22.4
323 * 7/1/2015 * 1 * 581 * 0 * 2/1/2017 * 19.4 * 22.2
324 * 7/31/2015 * 1 * 551 * 0 * 2/1/2017 * 18.4 * 21.2
325 * 8/15/2015 * 1 * 536 * 0 * 2/1/2017 * 17.9 * 20.7
326 * 9/2/2015 * 1 * 518 * 0 * 2/1/2017 * 17.3 * 20.1
327 * 9/8/2015 * 1 * 512 * 0 * 2/1/2017 * 17.1 * 19.9
328 * 9/26/2015 * 1 * 494 * 0 * 2/1/2017 * 16.5 * 19.3
329 * 6/10/2015 * 0 * 610 * 1 * 2/9/2017 * 20.3 * 23.1
330 * 6/13/2015 * 0 * 740 * 1 * 6/22/2017 * 24.7 * 27.5
331 * 10/15/2015 * 1 * 740 * 1 * 10/24/2017 * 24.7 * 27.5
Iclight
Every time you question the PFS with an erroneous post that is just made to confuse and give fear, I am going to repost my PFS DATA review. Even if the 248 PFS patient was in early 2016 the results would be significant.
DCVax-L GBM trial Result PFS Model based on IMUC Control DATA
Reposted now with updated working links.
Discloser: I am long this stock; I have no inside information; I am a clinical researcher.
Hypothesis 1: The Control Patients in the DCVax-L GBM trial should relapse at a rate similar to what was shown in the IMUC trial. The IMUC trial is the most similar to the DCVax-L GBM trial in terms of eligibility entry criteria. The progression free survival (PFS) was reported recently at the 2014 American Society of Clinical Oncology (ASCO) meeting.
https://www.dropbox.com/s/a90hj1507dd2ekr/bosch%20nwbo%203.PNG?dl=0
Hypothesis 2: Given that we know the number of PFS events in the total DCVax-L trial at this time (first interim analysis) is 66 December 2013;
https://www.dropbox.com/s/qy0zlxwehjf5f9l/nwbo%2066%20events.JPG?dl=0
And NWBO reported 248 PFS events on before 2/1/2017
https://www.dropbox.com/s/w60sbgacpzi28ck/bosch%20nwbo%201.PNG?dl=0
Then one can model using JMP(SAS) software, model the control arm PFS for the DCVaX-L trial to be the same as the corrected IMUC trial results and thus obtain an estimate of the probable number of events required in the control arm of the DCVax-L. When one does this with a Kaplan Meier plot, one obtains a result of 100 events in the control arm with the total number of patients in the control arm of 111. Then one can deduce that the number of events in the experimental arm for the DCVax-L trial would be 331- 111 or 148 events.
Hypothesis 3: Using the derived 148 PFS events in the experimental arm, one can model the experimental arm to be similar to the IMUC control arm trial results but, in this case only allow for just 148 events out of 220 total patients in the DCVax-L experimental arm.
When one does this with a Kaplan Meier plot, the data and curves are shown below. When one applies log-rank and Wilcoxon significance testing to the two curves one obtains a significant result of p<.0001
https://www.dropbox.com/s/o6270dlwrcx3wr8/PFS%20NWBO%20COMPARE%20jpg.JPG?dl=0
My best-educated hypothesis is that clearly, the DCVax-L trial is going to return a positive result on the primary end point
This result will be a practice changing result. Especially when one sees the plateau in the treatment curve. The nice thing about this PFS review also is that there is no crossover effect between the curves such as could occur with my prior overall survival analysis OS.
129619 Alphapuppy Ihub post
Just to put this into perspective the Stupp GMB trial PFS only increased 2 months by the addition of temazolamide (TMZ) (5 to 6.9 months). Yet this became almost immediately, the new gold standard of care in this disease and TMZ almost immediately became a blockbuster multi-billion dollar drug.
DCVaX-L increases in the operable patients even more than this and with none of the chemotherapy side effects and will quickly be the new standard of care in this disease.
Yes IRET still on sale. And it is been one heck of a sale. Basically it's been on sale since 2015 over 2 a half years ago!
EX
1. At ASCO in early June there were 231 OS events, which is just 2 events shy off 233 event OS minimum threshold. NWBO predicted that these remaining 2 events would occur in about 1 month ... by mid July.
What do you think, statistically and per your modeling etc, that the odds are that the 233 event threshold has not yet been crossed?
How many OS events do you think have occurred so far .... 237?
I have to take Bosch at his word of 2 events per month but I know that the event rate changes (reduces) as the total number of patients alive and still on the trial reduces.
Is there a benefit for NWBO allowing the trial to continue well beyond the 233 events?
Not from a statistical standpoint but they may have agreed to wait for x events to occur with the FDA
Do you think NWBO may have implemented a data-lock, and just not reported it yet?
NO i don't; Bosch would have disclosed that at his 8-31-2017 talk if they had. IMHO
2. Based on your modeling of the blinded phase 3 .... how do you think the results from the information arm confirm or strengthen your charts & predictions?
From one what I have seen it supports my model
3. Based on your most current modeling, what is your prediction regarding Primary Endpoint results .... number of months for treatment arm versus control arm?
Same for Secondary Endpoint OS number of months for each cohort?
Please see my graphs; unable to say anything about subset analysis.
Ex
The IMUC control group curves drive the model. Since the IMUC control patients and NWBO control group patients had a similar selection and initial treatment, they would likely have similar PFS survivals. If the NWBO controls do different than the IMUC controls then this model would not be as accurate.
For the worst case senerio described please review my prior post when I was modeling the tail of the curves, which this present model does not address.
AP post POST 121596
Good guy
Your comment is quite funny. That any company would rely on an individual named alpha puppy. Ha ha.
However I do have a number of years of experience doing this sort of clinical research. And have first authored my own peer reviewed works. And as I have the disclosed previously in this situation I have actual skin in the game.
Andes
My strength is that of a clinical researcher and someone who has been seeing these poor devastated glioblastoma multiforma patients for a number of years.
I have no idea what the FDA thinks, does or wants to do. It becomes kind of political perhaps at that point.
What I do know however is that with curves like this, it is very very difficult if not impossible for big Pharma or the FDA to ignore it.
AP
Ex
Nope nothing happened with the trial. It is part of the methodology of the modeling.
More events were posted in this model as early as possible for each graph, in order to be as to be as conservative as possible. This would in essence take out the longest potential follow ups and time factors first. Therefore, for the later dates, their would be less events than what probably actually occurred. Keep in mind that the total number of events however are accurate based on the IMUC modeling
When running my models I always like, in this situation, to look at worst case scenario's. In all probability, ACTUAL curves will be different with better survival rates then listed.
However what you need to understand, is that the actual difference between the two curves will be accurate And consistent with this modeling.
So the strength of this model is looking at the difference between the experimental arm and the placebo group.
So the actual curves probably will be slightly higher than what is shown. But the difference between the control and the experimental arm will be very similar to the modeling.
AP
REPOST with updated links
Data lock will equal a real date.
ie Say 9-1-2017 or whatever.
Then that date will be used as the "last date of Follow-up or Death" and the KM curves and all statistics will use that date to calculate the time factor (ie amount of time from a patients entry into the trial to the particular parameter measured such as progression or death or whatever is defined as an 'event'. Or if the patient has not experienced any event they will have a time factor = to the lock date minus their date of trial entry and randomization.
For patients that have not evented, they will be censored and not used for making the KM curve for any time that is greater than the difference of the lock date minus their particular data entry date or randomization date.
Please see this review and comparison of my PFS model results with the NEJM STUPP data. One can see how revolutionary this treatment will be as the STUPP protocol is arguably still the standard of Care (+/- Optune).
https://www.dropbox.com/s/ywsv4jyv7mkucxs/DCVacL%20compared%20to%20STUPP.JPG?dl=0
Also, note the Stupp gragh gives the number of patients at risk at various time intervals under the gragh so one knows how many patients data are left for the longer time periods out. IE those numbers below equal the total number of patients on the various trial arms minus those who have evented or who were censored.
For you to better understand this I include below the data I used to create the current model comparisons. So, in this case, the Date of entry is the dates given by Bosch at ASCO 2017 for the patient enrollment ramp. The treatment(1) or Placebo (2) was generated by a random number generator in excel in a 2 to 1 ratio for experimental and placebo respectively. Then the Control (0) group was manually given the time in days and the events directly based on the IMUC Control group data pro rata to compensate for the larger NWBO trial.
Then once the number of events were derived in the NWBO control group by this method, the number of events remaining was simply a subtraction of the number of PFS events that NWBO has given us on 2 separate occasions: Once in Dec 2013 66 PFS events for the whole group and another disclosed in Feb. 2017 or before when 248 events were disclosed.
Then the exact same process was used on the experimental patient group in that the events and time were placed in to be equal to the published IMUC control group KM PFS curves ... but here is the cool part ... the number of events was limited to 148 which was derived as noted above and by Dec 2013 only 66 events were placed prior to that date. Therefore there were significantly fewer events in the experimental DCVaxL arm than would have been expected had the experiment arm survived progression free at the same rate as was published by the IMUC control group curves.
Then it was a simple matter of inputting the time factor, the event/censor factor and the group placebo or experimental into the KM statistical software.
And walla the curves appear with the statistical comparison tests.
Derived Data for all 331 patients in the DCVax-L TRIAL
PT # * ENTRY * RX=1 Placebo=0 * DAYS * 1=event 0= censor * DATE EVENT or Censor * MONTHS * Plus 83d Mo
1 * 6/2/2008 * 1 * 53 * 1 * 7/25/2008 * 1.8 * 4.6
2 * 6/13/2008 * 0 * 53 * 1 * 8/5/2008 * 1.8 * 4.6
3 * 6/27/2008 * 1 * 53 * 1 * 8/19/2008 * 1.8 * 4.6
4 * 7/23/2008 * 0 * 53 * 1 * 9/14/2008 * 1.8 * 4.6
5 * 7/10/2008 * 1 * 85 * 1 * 10/3/2008 * 2.8 * 5.6
6 * 8/5/2008 * 0 * 85 * 1 * 10/29/2008 * 2.8 * 5.6
7 * 9/12/2008 * 1 * 85 * 1 * 12/6/2008 * 2.8 * 5.6
8 * 9/26/2008 * 1 * 95 * 1 * 12/30/2008 * 3.2 * 6
9 * 10/9/2008 * 1 * 95 * 1 * 1/12/2009 * 3.2 * 6
10 * 11/4/2008 * 0 * 85 * 1 * 1/28/2009 * 2.8 * 5.6
11 * 11/17/2008 * 0 * 95 * 1 * 2/20/2009 * 3.2 * 6
12 * 12/1/2008 * 0 * 95 * 1 * 3/6/2009 * 3.2 * 6
13 * 12/12/2008 * 0 * 105 * 1 * 3/27/2009 * 3.5 * 6.3
14 * 12/26/2008 * 0 * 105 * 1 * 4/10/2009 * 3.5 * 6.3
15 * 1/8/2009 * 0 * 112 * 1 * 4/30/2009 * 3.7 * 6.5
16 * 2/3/2009 * 1 * 105 * 1 * 5/19/2009 * 3.5 * 6.3
17 * 2/16/2009 * 1 * 105 * 1 * 6/1/2009 * 3.5 * 6.3
18 * 3/2/2009 * 0 * 112 * 1 * 6/22/2009 * 3.7 * 6.5
19 * 3/13/2009 * 0 * 112 * 1 * 7/3/2009 * 3.7 * 6.5
20 * 3/27/2009 * 0 * 112 * 1 * 7/17/2009 * 3.7 * 6.5
21 * 4/9/2009 * 1 * 112 * 1 * 7/30/2009 * 3.7 * 6.5
22 * 10/3/2011 * 0 * 120 * 1 * 1/31/2012 * 4 * 6.8
23 * 10/21/2011 * 0 * 120 * 1 * 2/18/2012 * 4 * 6.8
24 * 11/2/2011 * 0 * 120 * 1 * 3/1/2012 * 4 * 6.8
25 * 11/14/2011 * 1 * 112 * 1 * 3/5/2012 * 3.7 * 6.5
26 * 11/24/2011 * 0 * 120 * 1 * 3/23/2012 * 4 * 6.8
27 * 12/5/2011 * 0 * 120 * 1 * 4/3/2012 * 4 * 6.8
28 * 12/15/2011 * 1 * 112 * 1 * 4/5/2012 * 3.7 * 6.5
29 * 12/26/2011 * 1 * 112 * 1 * 4/16/2012 * 3.7 * 6.5
30 * 1/6/2012 * 0 * 120 * 1 * 5/5/2012 * 4 * 6.8
31 * 2/7/2012 * 0 * 122 * 1 * 6/8/2012 * 4.1 * 6.9
32 * 2/17/2012 * 1 * 120 * 1 * 6/16/2012 * 4 * 6.8
33 * 2/29/2012 * 0 * 122 * 1 * 6/30/2012 * 4.1 * 6.9
34 * 3/11/2012 * 1 * 120 * 1 * 7/9/2012 * 4 * 6.8
35 * 3/21/2012 * 1 * 120 * 1 * 7/19/2012 * 4 * 6.8
36 * 4/1/2012 * 0 * 123 * 1 * 8/2/2012 * 4.1 * 6.9
37 * 5/4/2012 * 0 * 123 * 1 * 9/4/2012 * 4.1 * 6.9
38 * 5/14/2012 * 1 * 120 * 1 * 9/11/2012 * 4 * 6.8
39 * 5/25/2012 * 1 * 120 * 1 * 9/22/2012 * 4 * 6.8
40 * 6/5/2012 * 0 * 126 * 1 * 10/9/2012 * 4.2 * 7
41 * 6/16/2012 * 1 * 120 * 1 * 10/14/2012 * 4 * 6.8
42 * 6/27/2012 * 0 * 126 * 1 * 10/31/2012 * 4.2 * 7
43 * 8/20/2012 * 1 * 122 * 1 * 12/20/2012 * 4.1 * 6.9
44 * 7/29/2012 * 0 * 151 * 1 * 12/27/2012 * 5 * 7.8
45 * 8/9/2012 * 0 * 151 * 1 * 1/7/2013 * 5 * 7.8
46 * 9/10/2012 * 1 * 122 * 1 * 1/10/2013 * 4.1 * 6.9
47 * 9/21/2012 * 1 * 123 * 1 * 1/22/2013 * 4.1 * 6.9
48 * 8/30/2012 * 0 * 158 * 1 * 2/4/2013 * 5.3 * 8.1
49 * 11/3/2012 * 1 * 123 * 1 * 3/6/2013 * 4.1 * 6.9
50 * 11/14/2012 * 1 * 126 * 1 * 3/20/2013 * 4.2 * 7
51 * 10/23/2012 * 0 * 158 * 1 * 3/30/2013 * 5.3 * 8.1
52 * 12/16/2012 * 1 * 126 * 1 * 4/21/2013 * 4.2 * 7
53 * 11/25/2012 * 0 * 158 * 1 * 5/2/2013 * 5.3 * 8.1
54 * 12/6/2012 * 0 * 172 * 1 * 5/27/2013 * 5.7 * 8.5
55 * 1/18/2013 * 1 * 151 * 1 * 6/18/2013 * 5 * 7.8
56 * 1/29/2013 * 1 * 151 * 1 * 6/29/2013 * 5 * 7.8
57 * 2/8/2013 * 1 * 158 * 1 * 7/16/2013 * 5.3 * 8.1
58 * 2/19/2013 * 0 * 172 * 1 * 8/10/2013 * 5.7 * 8.5
59 * 3/2/2013 * 0 * 172 * 1 * 8/21/2013 * 5.7 * 8.5
60 * 4/3/2013 * 1 * 158 * 1 * 9/8/2013 * 5.3 * 8.1
61 * 4/25/2013 * 1 * 158 * 1 * 9/30/2013 * 5.3 * 8.1
62 * 4/14/2013 * 0 * 175 * 1 * 10/6/2013 * 5.8 * 8.6
63 * 5/6/2013 * 0 * 175 * 1 * 10/28/2013 * 5.8 * 8.6
64 * 5/15/2013 * 0 * 182 * 1 * 11/13/2013 * 6.1 * 8.9
65 * 5/30/2013 * 1 * 172 * 1 * 11/18/2013 * 5.7 * 8.5
66 * 5/26/2013 * 0 * 182 * 1 * 11/24/2013 * 6.1 * 8.9
67 * 6/13/2013 * 1 * 172 * 1 * 12/2/2013 * 5.7 * 8.5
68 * 6/17/2013 * 1 * 172 * 1 * 12/6/2013 * 5.7 * 8.5
69 * 6/22/2013 * 1 * 175 * 1 * 12/14/2013 * 5.8 * 8.6
70 * 7/5/2013 * 1 * 175 * 1 * 12/27/2013 * 5.8 * 8.6
71 * 7/14/2013 * 1 * 182 * 1 * 1/12/2014 * 6.1 * 8.9
72 * 7/19/2013 * 1 * 182 * 1 * 1/17/2014 * 6.1 * 8.9
73 * 7/10/2013 * 0 * 200 * 1 * 1/26/2014 * 6.7 * 9.5
74 * 7/23/2013 * 0 * 200 * 1 * 2/8/2014 * 6.7 * 9.5
75 * 8/6/2013 * 1 * 200 * 1 * 2/22/2014 * 6.7 * 9.5
76 * 8/15/2013 * 1 * 200 * 1 * 3/3/2014 * 6.7 * 9.5
77 * 8/10/2013 * 0 * 206 * 1 * 3/4/2014 * 6.9 * 9.7
78 * 8/19/2013 * 1 * 206 * 1 * 3/13/2014 * 6.9 * 9.7
79 * 9/2/2013 * 1 * 206 * 1 * 3/27/2014 * 6.9 * 9.7
80 * 9/7/2013 * 0 * 206 * 1 * 4/1/2014 * 6.9 * 9.7
81 * 9/11/2013 * 1 * 210 * 1 * 4/9/2014 * 7 * 9.8
82 * 9/16/2013 * 1 * 210 * 1 * 4/14/2014 * 7 * 9.8
83 * 9/20/2013 * 0 * 210 * 1 * 4/18/2014 * 7 * 9.8
84 * 10/13/2013 * 0 * 210 * 1 * 5/11/2014 * 7 * 9.8
85 * 10/4/2013 * 1 * 224 * 1 * 5/16/2014 * 7.5 * 10.3
86 * 10/8/2013 * 1 * 224 * 1 * 5/20/2014 * 7.5 * 10.3
87 * 10/17/2013 * 0 * 224 * 1 * 5/29/2014 * 7.5 * 10.3
88 * 10/22/2013 * 0 * 224 * 1 * 6/3/2014 * 7.5 * 10.3
89 * 10/26/2013 * 1 * 260 * 1 * 7/13/2014 * 8.7 * 11.5
90 * 11/9/2013 * 1 * 260 * 1 * 7/27/2014 * 8.7 * 11.5
91 * 11/13/2013 * 1 * 278 * 1 * 8/18/2014 * 9.3 * 12.1
92 * 11/18/2013 * 1 * 278 * 1 * 8/23/2014 * 9.3 * 12.1
93 * 12/15/2013 * 0 * 260 * 1 * 9/1/2014 * 8.7 * 11.5
94 * 12/2/2013 * 1 * 290 * 1 * 9/18/2014 * 9.7 * 12.5
95 * 4/21/2014 * 1 * 151 * 1 * 9/19/2014 * 5 * 7.8
96 * 12/6/2013 * 1 * 290 * 1 * 9/22/2014 * 9.7 * 12.5
97 * 12/11/2013 * 1 * 300 * 1 * 10/7/2014 * 10 * 12.8
98 * 1/20/2014 * 0 * 260 * 1 * 10/7/2014 * 8.7 * 11.5
99 * 5/4/2014 * 1 * 158 * 1 * 10/9/2014 * 5.3 * 8.1
100 * 5/13/2014 * 1 * 158 * 1 * 10/18/2014 * 5.3 * 8.1
101 * 8/31/2014 * 1 * 53 * 1 * 10/23/2014 * 1.8 * 4.6
102 * 9/3/2014 * 1 * 53 * 1 * 10/26/2014 * 1.8 * 4.6
103 * 1/25/2014 * 0 * 278 * 1 * 10/30/2014 * 9.3 * 12.1
104 * 12/29/2013 * 1 * 312 * 1 * 11/6/2014 * 10.4 * 13.2
105 * 5/18/2014 * 1 * 172 * 1 * 11/6/2014 * 5.7 * 8.5
106 * 1/2/2014 * 1 * 315 * 1 * 11/13/2014 * 10.5 * 13.3
107 * 6/1/2014 * 1 * 172 * 1 * 11/20/2014 * 5.7 * 8.5
108 * 1/7/2014 * 1 * 318 * 1 * 11/21/2014 * 10.6 * 13.4
109 * 6/6/2014 * 1 * 175 * 1 * 11/28/2014 * 5.8 * 8.6
110 * 3/2/2014 * 0 * 278 * 1 * 12/5/2014 * 9.3 * 12.1
111 * 9/12/2014 * 1 * 85 * 1 * 12/6/2014 * 2.8 * 5.6
112 * 6/18/2014 * 1 * 182 * 1 * 12/17/2014 * 6.1 * 8.9
113 * 1/29/2014 * 1 * 322 * 1 * 12/17/2014 * 10.7 * 13.5
114 * 2/3/2014 * 1 * 321 * 1 * 12/21/2014 * 10.7 * 13.5
115 * 2/7/2014 * 1 * 323 * 1 * 12/27/2014 * 10.8 * 13.6
116 * 9/24/2014 * 1 * 95 * 1 * 12/28/2014 * 3.2 * 6
117 * 3/16/2014 * 0 * 290 * 1 * 12/31/2014 * 9.7 * 12.5
118 * 3/25/2014 * 0 * 290 * 1 * 1/9/2015 * 9.7 * 12.5
119 * 2/21/2014 * 1 * 324 * 1 * 1/11/2015 * 10.8 * 13.6
120 * 2/25/2014 * 1 * 323 * 1 * 1/14/2015 * 10.8 * 13.6
121 * 10/2/2014 * 1 * 105 * 1 * 1/15/2015 * 3.5 * 6.3
122 * 10/5/2014 * 1 * 105 * 1 * 1/18/2015 * 3.5 * 6.3
123 * 3/7/2014 * 1 * 320 * 1 * 1/21/2015 * 10.7 * 13.5
124 * 10/11/2014 * 1 * 112 * 1 * 1/31/2015 * 3.7 * 6.5
125 * 4/12/2014 * 0 * 300 * 1 * 2/6/2015 * 10 * 12.8
126 * 3/29/2014 * 1 * 325 * 1 * 2/17/2015 * 10.8 * 13.6
127 * 4/3/2014 * 1 * 325 * 1 * 2/22/2015 * 10.8 * 13.6
128 * 4/30/2014 * 0 * 300 * 1 * 2/24/2015 * 10 * 12.8
129 * 11/4/2014 * 1 * 112 * 1 * 2/24/2015 * 3.7 * 6.5
130 * 4/7/2014 * 1 * 325 * 1 * 2/26/2015 * 10.8 * 13.6
131 * 11/7/2014 * 1 * 120 * 1 * 3/7/2015 * 4 * 6.8
132 * 11/13/2014 * 1 * 120 * 1 * 3/13/2015 * 4 * 6.8
133 * 5/9/2014 * 0 * 310 * 1 * 3/15/2015 * 10.3 * 13.1
134 * 11/25/2014 * 1 * 120 * 1 * 3/25/2015 * 4 * 6.8
135 * 10/26/2014 * 0 * 151 * 1 * 3/26/2015 * 5 * 7.8
136 * 10/29/2014 * 0 * 151 * 1 * 3/29/2015 * 5 * 7.8
137 * 5/22/2014 * 0 * 312 * 1 * 3/30/2015 * 10.4 * 13.2
138 * 12/3/2014 * 1 * 120 * 1 * 4/2/2015 * 4 * 6.8
139 * 12/6/2014 * 1 * 122 * 1 * 4/7/2015 * 4.1 * 6.9
140 * 11/1/2014 * 0 * 158 * 1 * 4/8/2015 * 5.3 * 8.1
141 * 12/9/2014 * 1 * 122 * 1 * 4/10/2015 * 4.1 * 6.9
142 * 11/10/2014 * 0 * 158 * 1 * 4/17/2015 * 5.3 * 8.1
143 * 12/18/2014 * 1 * 123 * 1 * 4/20/2015 * 4.1 * 6.9
144 * 6/9/2014 * 0 * 315 * 1 * 4/20/2015 * 10.5 * 13.3
145 * 11/19/2014 * 0 * 158 * 1 * 4/26/2015 * 5.3 * 8.1
146 * 6/12/2014 * 0 * 318 * 1 * 4/26/2015 * 10.6 * 13.4
147 * 6/15/2014 * 0 * 319 * 1 * 4/30/2015 * 10.6 * 13.4
148 * 12/27/2014 * 1 * 126 * 1 * 5/2/2015 * 4.2 * 7
149 * 11/22/2014 * 0 * 172 * 1 * 5/13/2015 * 5.7 * 8.5
150 * 12/1/2014 * 0 * 172 * 1 * 5/22/2015 * 5.7 * 8.5
151 * 7/6/2014 * 0 * 320 * 1 * 5/22/2015 * 10.7 * 13.5
152 * 12/30/2014 * 1 * 151 * 1 * 5/30/2015 * 5 * 7.8
153 * 7/15/2014 * 0 * 322 * 1 * 6/2/2015 * 10.7 * 13.5
154 * 1/5/2015 * 1 * 151 * 1 * 6/5/2015 * 5 * 7.8
155 * 12/15/2014 * 0 * 172 * 1 * 6/5/2015 * 5.7 * 8.5
156 * 7/24/2014 * 0 * 321 * 1 * 6/10/2015 * 10.7 * 13.5
157 * 7/27/2014 * 0 * 323 * 1 * 6/15/2015 * 10.8 * 13.6
158 * 12/24/2014 * 0 * 175 * 1 * 6/17/2015 * 5.8 * 8.6
159 * 1/14/2015 * 1 * 158 * 1 * 6/21/2015 * 5.3 * 8.1
160 * 1/2/2015 * 0 * 175 * 1 * 6/26/2015 * 5.8 * 8.6
161 * 6/21/2014 * 1 * 380 * 1 * 7/6/2015 * 12.7 * 15.5
162 * 1/8/2015 * 0 * 182 * 1 * 7/9/2015 * 6.1 * 8.9
163 * 6/27/2014 * 1 * 380 * 1 * 7/12/2015 * 12.7 * 15.5
164 * 1/26/2015 * 1 * 172 * 1 * 7/17/2015 * 5.7 * 8.5
165 * 8/28/2014 * 0 * 324 * 1 * 7/18/2015 * 10.8 * 13.6
166 * 1/29/2015 * 1 * 172 * 1 * 7/20/2015 * 5.7 * 8.5
167 * 2/1/2015 * 1 * 172 * 1 * 7/23/2015 * 5.7 * 8.5
168 * 9/6/2014 * 0 * 324 * 1 * 7/27/2015 * 10.8 * 13.6
169 * 7/3/2014 * 1 * 390 * 1 * 7/28/2015 * 13 * 15.8
170 * 9/18/2014 * 0 * 320 * 1 * 8/4/2015 * 10.7 * 13.5
171 * 9/15/2014 * 0 * 323 * 1 * 8/4/2015 * 10.8 * 13.6
172 * 2/13/2015 * 1 * 175 * 1 * 8/7/2015 * 5.8 * 8.6
173 * 9/27/2014 * 0 * 320 * 1 * 8/13/2015 * 10.7 * 13.5
174 * 9/30/2014 * 0 * 325 * 1 * 8/21/2015 * 10.8 * 13.6
175 * 2/25/2015 * 1 * 182 * 1 * 8/26/2015 * 6.1 * 8.9
176 * 10/17/2014 * 0 * 325 * 1 * 9/7/2015 * 10.8 * 13.6
177 * 10/20/2014 * 0 * 325 * 1 * 9/10/2015 * 10.8 * 13.6
178 * 7/9/2014 * 1 * 430 * 1 * 9/12/2015 * 14.3 * 17.1
179 * 10/23/2014 * 0 * 325 * 1 * 9/13/2015 * 10.8 * 13.6
180 * 7/12/2014 * 1 * 430 * 1 * 9/15/2015 * 14.3 * 17.1
181 * 3/3/2015 * 1 * 200 * 1 * 9/19/2015 * 6.7 * 9.5
182 * 3/6/2015 * 1 * 200 * 1 * 9/22/2015 * 6.7 * 9.5
183 * 7/21/2014 * 1 * 435 * 1 * 9/29/2015 * 14.5 * 17.3
184 * 3/15/2015 * 1 * 206 * 1 * 10/7/2015 * 6.9 * 9.7
185 * 8/1/2014 * 1 * 440 * 1 * 10/15/2015 * 14.7 * 17.5
186 * 3/21/2015 * 1 * 210 * 1 * 10/17/2015 * 7 * 9.8
187 * 3/24/2015 * 1 * 224 * 1 * 11/3/2015 * 7.5 * 10.3
188 * 3/27/2015 * 1 * 224 * 1 * 11/6/2015 * 7.5 * 10.3
189 * 8/4/2014 * 1 * 470 * 1 * 11/17/2015 * 15.7 * 18.5
190 * 8/7/2014 * 1 * 470 * 1 * 11/20/2015 * 15.7 * 18.5
191 * 8/16/2014 * 1 * 480 * 1 * 12/9/2015 * 16 * 18.8
192 * 4/8/2015 * 1 * 260 * 1 * 12/24/2015 * 8.7 * 11.5
193 * 7/28/2015 * 1 * 151 * 1 * 12/26/2015 * 5 * 7.8
194 * 8/3/2015 * 1 * 158 * 1 * 1/8/2016 * 5.3 * 8.1
195 * 8/9/2015 * 1 * 158 * 1 * 1/14/2016 * 5.3 * 8.1
196 * 4/17/2015 * 1 * 278 * 1 * 1/20/2016 * 9.3 * 12.1
197 * 8/19/2014 * 1 * 520 * 1 * 1/21/2016 * 17.3 * 20.1
198 * 1/20/2015 * 0 * 380 * 1 * 2/4/2016 * 12.7 * 15.5
199 * 4/23/2015 * 1 * 290 * 1 * 2/7/2016 * 9.7 * 12.5
200 * 1/23/2015 * 0 * 380 * 1 * 2/7/2016 * 12.7 * 15.5
201 * 4/26/2015 * 1 * 290 * 1 * 2/10/2016 * 9.7 * 12.5
202 * 2/7/2015 * 0 * 380 * 1 * 2/22/2016 * 12.7 * 15.5
203 * 5/2/2015 * 1 * 300 * 1 * 2/26/2016 * 10 * 12.8
204 * 2/10/2015 * 0 * 390 * 1 * 3/6/2016 * 13 * 15.8
205 * 2/16/2015 * 0 * 390 * 1 * 3/12/2016 * 13 * 15.8
206 * 5/8/2015 * 1 * 312 * 1 * 3/15/2016 * 10.4 * 13.2
207 * 5/11/2015 * 1 * 315 * 1 * 3/21/2016 * 10.5 * 13.3
208 * 5/14/2015 * 1 * 318 * 1 * 3/27/2016 * 10.6 * 13.4
209 * 5/26/2015 * 1 * 320 * 1 * 4/10/2016 * 10.7 * 13.5
210 * 6/7/2015 * 1 * 321 * 1 * 4/23/2016 * 10.7 * 13.5
211 * 2/19/2015 * 0 * 430 * 1 * 4/24/2016 * 14.3 * 17.1
212 * 2/28/2015 * 0 * 430 * 1 * 5/3/2016 * 14.3 * 17.1
213 * 6/16/2015 * 1 * 324 * 1 * 5/5/2016 * 10.8 * 13.6
214 * 6/22/2015 * 1 * 324 * 1 * 5/11/2016 * 10.8 * 13.6
215 * 6/28/2015 * 1 * 320 * 1 * 5/13/2016 * 10.7 * 13.5
216 * 3/9/2015 * 0 * 435 * 1 * 5/17/2016 * 14.5 * 17.3
217 * 7/13/2015 * 1 * 325 * 1 * 6/2/2016 * 10.8 * 13.6
218 * 7/16/2015 * 1 * 325 * 1 * 6/5/2016 * 10.8 * 13.6
219 * 3/30/2015 * 0 * 435 * 1 * 6/7/2016 * 14.5 * 17.3
220 * 7/19/2015 * 1 * 325 * 1 * 6/8/2016 * 10.8 * 13.6
221 * 4/2/2015 * 0 * 440 * 1 * 6/15/2016 * 14.7 * 17.5
222 * 4/14/2015 * 0 * 440 * 1 * 6/27/2016 * 14.7 * 17.5
223 * 4/20/2015 * 0 * 470 * 1 * 8/2/2016 * 15.7 * 18.5
224 * 8/12/2015 * 1 * 380 * 1 * 8/26/2016 * 12.7 * 15.5
225 * 5/17/2015 * 0 * 470 * 1 * 8/29/2016 * 15.7 * 18.5
226 * 8/25/2014 * 1 * 740 * 1 * 9/3/2016 * 24.7 * 27.5
227 * 5/23/2015 * 0 * 480 * 1 * 9/14/2016 * 16 * 18.8
228 * 8/24/2015 * 1 * 390 * 1 * 9/17/2016 * 13 * 15.8
229 * 5/29/2015 * 0 * 480 * 1 * 9/20/2016 * 16 * 18.8
230 * 8/27/2015 * 1 * 390 * 1 * 9/20/2016 * 13 * 15.8
231 * 6/1/2015 * 0 * 520 * 1 * 11/2/2016 * 17.3 * 20.1
232 * 8/30/2015 * 1 * 430 * 1 * 11/2/2016 * 14.3 * 17.1
233 * 9/5/2015 * 1 * 435 * 1 * 11/13/2016 * 14.5 * 17.3
234 * 9/11/2015 * 1 * 440 * 1 * 11/24/2016 * 14.7 * 17.5
235 * 9/14/2015 * 1 * 440 * 1 * 11/27/2016 * 14.7 * 17.5
236 * 9/17/2015 * 1 * 470 * 1 * 12/30/2016 * 15.7 * 18.5
237 * 9/29/2015 * 1 * 480 * 1 * 1/21/2017 * 16 * 18.8
238 * 8/13/2014 * 0 * 902.2048193 * 1 * 2/1/2017 * 30.1 * 32.9
239 * 10/5/2015 * 0 * 485 * 0 * 2/1/2017 * 16.2 * 19
240 * 9/23/2015 * 0 * 497 * 0 * 2/1/2017 * 16.6 * 19.4
241 * 9/20/2015 * 0 * 500 * 0 * 2/1/2017 * 16.7 * 19.5
242 * 8/21/2015 * 0 * 530 * 0 * 2/1/2017 * 17.7 * 20.5
243 * 8/18/2015 * 0 * 533 * 0 * 2/1/2017 * 17.8 * 20.6
244 * 8/6/2015 * 0 * 545 * 0 * 2/1/2017 * 18.2 * 21
245 * 7/22/2015 * 0 * 560 * 0 * 2/1/2017 * 18.7 * 21.5
246 * 7/10/2015 * 0 * 572 * 0 * 2/1/2017 * 19.1 * 21.9
247 * 7/7/2015 * 0 * 575 * 0 * 2/1/2017 * 19.2 * 22
248 * 7/4/2015 * 0 * 578 * 0 * 2/1/2017 * 19.3 * 22.1
249 * 6/19/2015 * 0 * 593 * 0 * 2/1/2017 * 19.8 * 22.6
250 * 6/4/2013 * 1 * 1337.95122 * 1 * 2/1/2017 * 44.6 * 47.4
251 * 6/3/2014 * 1 * 973.0481928 * 1 * 2/1/2017 * 32.4 * 35.2
252 * 11/16/2014 * 1 * 807.746988 * 1 * 2/1/2017 * 26.9 * 29.7
253 * 2/22/2015 * 1 * 710 * 1 * 2/1/2017 * 23.7 * 26.5
254 * 4/11/2015 * 1 * 662 * 1 * 2/1/2017 * 22.1 * 24.9
255 * 7/25/2015 * 1 * 557 * 1 * 2/1/2017 * 18.6 * 21.4
256 * 10/2/2015 * 1 * 488 * 1 * 2/1/2017 * 16.3 * 19.1
257 * 8/18/2008 * 1 * 3089 * 0 * 2/1/2017 * 103 * 105.8
258 * 9/1/2008 * 1 * 3075 * 0 * 2/1/2017 * 102.5 * 105.3
259 * 10/22/2008 * 1 * 3024 * 0 * 2/1/2017 * 100.8 * 103.6
260 * 1/21/2009 * 1 * 2933 * 0 * 2/1/2017 * 97.8 * 100.6
261 * 4/15/2009 * 1 * 2849 * 0 * 2/1/2017 * 95 * 97.8
262 * 10/11/2011 * 1 * 1939.2 * 0 * 2/1/2017 * 64.6 * 67.4
263 * 1/17/2012 * 1 * 1842 * 0 * 2/1/2017 * 61.4 * 64.2
264 * 1/27/2012 * 1 * 1831.2 * 0 * 2/1/2017 * 61 * 63.8
265 * 4/12/2012 * 1 * 1755.6 * 0 * 2/1/2017 * 58.5 * 61.3
266 * 4/23/2012 * 1 * 1744.8 * 0 * 2/1/2017 * 58.2 * 61
267 * 7/7/2012 * 1 * 1669.2 * 0 * 2/1/2017 * 55.6 * 58.4
268 * 7/18/2012 * 1 * 1658.4 * 0 * 2/1/2017 * 55.3 * 58.1
269 * 10/2/2012 * 1 * 1582.8 * 0 * 2/1/2017 * 52.8 * 55.6
270 * 10/13/2012 * 1 * 1572 * 0 * 2/1/2017 * 52.4 * 55.2
271 * 12/27/2012 * 1 * 1496.4 * 0 * 2/1/2017 * 49.9 * 52.7
272 * 1/7/2013 * 1 * 1485.6 * 0 * 2/1/2017 * 49.5 * 52.3
273 * 3/13/2013 * 1 * 1420.8 * 0 * 2/1/2017 * 47.4 * 50.2
274 * 3/24/2013 * 1 * 1410 * 0 * 2/1/2017 * 47 * 49.8
275 * 6/8/2013 * 1 * 1333.426829 * 0 * 2/1/2017 * 44.4 * 47.2
276 * 6/26/2013 * 1 * 1315.329268 * 0 * 2/1/2017 * 43.8 * 46.6
277 * 7/1/2013 * 1 * 1310.804878 * 0 * 2/1/2017 * 43.7 * 46.5
278 * 7/28/2013 * 1 * 1283.658537 * 0 * 2/1/2017 * 42.8 * 45.6
279 * 8/1/2013 * 1 * 1279.134146 * 0 * 2/1/2017 * 42.6 * 45.4
280 * 8/24/2013 * 1 * 1256.512195 * 0 * 2/1/2017 * 41.9 * 44.7
281 * 8/29/2013 * 1 * 1251.987805 * 0 * 2/1/2017 * 41.7 * 44.5
282 * 9/25/2013 * 1 * 1224.841463 * 0 * 2/1/2017 * 40.8 * 43.6
283 * 9/29/2013 * 1 * 1220.317073 * 0 * 2/1/2017 * 40.7 * 43.5
284 * 10/31/2013 * 1 * 1188.646341 * 0 * 2/1/2017 * 39.6 * 42.4
285 * 11/4/2013 * 1 * 1184.121951 * 0 * 2/1/2017 * 39.5 * 42.3
286 * 11/22/2013 * 1 * 1166.02439 * 0 * 2/1/2017 * 38.9 * 41.7
287 * 11/27/2013 * 1 * 1161.5 * 0 * 2/1/2017 * 38.7 * 41.5
288 * 12/20/2013 * 1 * 1138.878049 * 0 * 2/1/2017 * 38 * 40.8
289 * 12/24/2013 * 1 * 1134.353659 * 0 * 2/1/2017 * 37.8 * 40.6
290 * 1/11/2014 * 1 * 1116.256098 * 0 * 2/1/2017 * 37.2 * 40
291 * 1/16/2014 * 1 * 1111.731707 * 0 * 2/1/2017 * 37.1 * 39.9
292 * 2/12/2014 * 1 * 1084.585366 * 0 * 2/1/2017 * 36.2 * 39
293 * 2/16/2014 * 1 * 1080.060976 * 0 * 2/1/2017 * 36 * 38.8
294 * 3/11/2014 * 1 * 1057.439024 * 0 * 2/1/2017 * 35.2 * 38
295 * 3/20/2014 * 1 * 1048.390244 * 0 * 2/1/2017 * 34.9 * 37.7
296 * 4/16/2014 * 1 * 1021.243902 * 0 * 2/1/2017 * 34 * 36.8
297 * 4/25/2014 * 1 * 1012.195122 * 0 * 2/1/2017 * 33.7 * 36.5
298 * 5/27/2014 * 1 * 980.5243902 * 0 * 2/1/2017 * 32.7 * 35.5
299 * 6/24/2014 * 1 * 952.3855422 * 0 * 2/1/2017 * 31.7 * 34.5
300 * 6/30/2014 * 1 * 946.4819277 * 0 * 2/1/2017 * 31.5 * 34.3
301 * 7/18/2014 * 1 * 928.7710843 * 0 * 2/1/2017 * 31 * 33.8
302 * 7/30/2014 * 1 * 916.9638554 * 0 * 2/1/2017 * 30.6 * 33.4
303 * 8/10/2014 * 1 * 905.1566265 * 0 * 2/1/2017 * 30.2 * 33
304 * 8/22/2014 * 1 * 893.3493976 * 0 * 2/1/2017 * 29.8 * 32.6
305 * 9/9/2014 * 1 * 875.6385542 * 0 * 2/1/2017 * 29.2 * 32
306 * 9/21/2014 * 1 * 863.8313253 * 0 * 2/1/2017 * 28.8 * 31.6
307 * 10/8/2014 * 1 * 846.1204819 * 0 * 2/1/2017 * 28.2 * 31
308 * 10/14/2014 * 1 * 840.2168675 * 0 * 2/1/2017 * 28 * 30.8
309 * 11/28/2014 * 1 * 795.939759 * 0 * 2/1/2017 * 26.5 * 29.3
310 * 12/12/2014 * 1 * 781.1807229 * 0 * 2/1/2017 * 26 * 28.8
311 * 12/21/2014 * 1 * 772.3253012 * 0 * 2/1/2017 * 25.7 * 28.5
312 * 1/11/2015 * 1 * 751.6626506 * 0 * 2/1/2017 * 25.1 * 27.9
313 * 1/17/2015 * 1 * 745.7590361 * 0 * 2/1/2017 * 24.9 * 27.7
314 * 2/4/2015 * 1 * 728 * 0 * 2/1/2017 * 24.3 * 27.1
315 * 3/12/2015 * 1 * 692 * 0 * 2/1/2017 * 23.1 * 25.9
316 * 3/18/2015 * 1 * 686 * 0 * 2/1/2017 * 22.9 * 25.7
317 * 4/5/2015 * 1 * 668 * 0 * 2/1/2017 * 22.3 * 25.1
318 * 4/29/2015 * 1 * 644 * 0 * 2/1/2017 * 21.5 * 24.3
319 * 5/5/2015 * 1 * 638 * 0 * 2/1/2017 * 21.3 * 24.1
320 * 5/20/2015 * 1 * 623 * 0 * 2/1/2017 * 20.8 * 23.6
321 * 6/4/2015 * 1 * 608 * 0 * 2/1/2017 * 20.3 * 23.1
322 * 6/25/2015 * 1 * 587 * 0 * 2/1/2017 * 19.6 * 22.4
323 * 7/1/2015 * 1 * 581 * 0 * 2/1/2017 * 19.4 * 22.2
324 * 7/31/2015 * 1 * 551 * 0 * 2/1/2017 * 18.4 * 21.2
325 * 8/15/2015 * 1 * 536 * 0 * 2/1/2017 * 17.9 * 20.7
326 * 9/2/2015 * 1 * 518 * 0 * 2/1/2017 * 17.3 * 20.1
327 * 9/8/2015 * 1 * 512 * 0 * 2/1/2017 * 17.1 * 19.9
328 * 9/26/2015 * 1 * 494 * 0 * 2/1/2017 * 16.5 * 19.3
329 * 6/10/2015 * 0 * 610 * 1 * 2/9/2017 * 20.3 * 23.1
330 * 6/13/2015 * 0 * 740 * 1 * 6/22/2017 * 24.7 * 27.5
331 * 10/15/2015 * 1 * 740 * 1 * 10/24/2017 * 24.7 * 27.5
DCVax-L GBM trial Result PFS Model based on IMUC Control DATA
Reposted now with updated working links.
Discloser: I am long this stock; I have no inside information; I am a clinical researcher.
Hypothesis 1: The Control Patients in the DCVax-L GBM trial should relapse at a rate similar to what was shown in the IMUC trial. The IMUC trial is the most similar to the DCVax-L GBM trial in terms of eligibility entry criteria. The progression free survival (PFS) was reported recently at the 2014 American Society of Clinical Oncology (ASCO) meeting.
https://www.dropbox.com/s/a90hj1507dd2ekr/bosch%20nwbo%203.PNG?dl=0
Hypothesis 2: Given that we know the number of PFS events in the total DCVax-L trial at this time (first interim analysis) is 66 December 2013;
https://www.dropbox.com/s/qy0zlxwehjf5f9l/nwbo%2066%20events.JPG?dl=0
And NWBO reported 248 PFS events on before 2/1/2017
https://www.dropbox.com/s/w60sbgacpzi28ck/bosch%20nwbo%201.PNG?dl=0
Then one can model using JMP(SAS) software, model the control arm PFS for the DCVaX-L trial to be the same as the corrected IMUC trial results and thus obtain an estimate of the probable number of events required in the control arm of the DCVax-L. When one does this with a Kaplan Meier plot, one obtains a result of 100 events in the control arm with the total number of patients in the control arm of 111. Then one can deduce that the number of events in the experimental arm for the DCVax-L trial would be 331- 111 or 148 events.
Hypothesis 3: Using the derived 148 PFS events in the experimental arm, one can model the experimental arm to be similar to the IMUC control arm trial results but, in this case only allow for just 148 events out of 220 total patients in the DCVax-L experimental arm.
When one does this with a Kaplan Meier plot, the data and curves are shown below. When one applies log-rank and Wilcoxon significance testing to the two curves one obtains a significant result of p<.0001
https://www.dropbox.com/s/o6270dlwrcx3wr8/PFS%20NWBO%20COMPARE%20jpg.JPG?dl=0
My best-educated hypothesis is that clearly, the DCVax-L trial is going to return a positive result on the primary end point
This result will be a practice changing result. Especially when one sees the plateau in the treatment curve. The nice thing about this PFS review also is that there is no crossover effect between the curves such as could occur with my prior overall survival analysis OS.
129619 Alphapuppy Ihub post
Just to put this into perspective the Stupp GMB trial PFS only increased 2 months by the addition of temazolamide (TMZ) (5 to 6.9 months). Yet this became almost immediately, the new gold standard of care in this disease and TMZ almost immediately became a blockbuster multi-billion dollar drug.
DCVaX-L increases in the operable patients even more than this and with none of the chemotherapy side effects and will quickly be the new standard of care in this disease.
Tadasana
Nope, I have not sent any of the model data to NWBO. I figured that they would have more info than me!!
But your point is well taken, as being lawyers, they might have more info, but absolutely no understanding of how to get good data and information from what they have.
I would assume that they would monitor this board, but after review of that recent Lawsuit where they didn't even know they were having a judgment hearing, it does make me wonder if they do monitor this or anything else besides the getting more money issue.
ALSO, I just found out that as of 9-1-2017 Dropbox was dropping their public folder so I have been informed that all my prior links will no longer work.
Please contact me if any of you would want new links to the visual data located in my previous Posts.
IF there is that desire I can re-post the posts with updated links.
AP
Jammy
Here is the model with a lock date of 8-15-2015.
Still PFS is significant. I expect however that OS would not be significant at this time.
Note only 313 cases at this time as some participants were randomized after this lock date.
https://www.dropbox.com/s/ml1mpe0q0wt9ue3/dcfax%20PFS%20model%20lock%20date%20aug%202015%20-%20Copy.JPG?dl=0
AP
China
excerpt from your post
"Re: antihama Post# 132371
It's unbelievable really. There are just too many different pieces of evidence that point to either total failure, major complications,"
Wondering therefore what you mean by major complication?
AP
China
Median is just one point on the curves.
Look at the entire curves to see the differences.
AP
Abeta
AMEN to that.
Having spent over 30 years seeing people devastated by this EMPEROR of all CANCERS it is hard to express how good and beautiful a plateau in a PFS GBM survival curve is.
AP
Thanks Senti
You are as smart as ever.
I do have curves both ways. With the added 83 days and without. I initially ran the curves without the added 83 days but when I reviewed one of my prior posts I thought IMUC randomization occurred after RT TMZ and DCVaX-L Trial entry date was earlier.
Well here is the curves WITHOUT the added 83 days.
Here it is without the added 83 days.
https://dl.dropboxusercontent.com/u/11047753/PFS%20NWBO%20COMPARE%20jpg.JPG
Here are the curves WITH the 83 days added.
https://dl.dropboxusercontent.com/u/11047753/PFS%20NWBO%20COMPARE%20plus%2083.JPG
AP