Replies to post #134906 on NorthWest Biotherapeutics Inc (NWBO)

[alphapuppy]

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

[Rootjim]

The last part you state that DCVax-L does not need chemotherapy,so no side effects. From my understanding is DCVax-L is used with chemotherapy. So maybe you can clarify this.

[hankmanhub]

Even if the 248 PFS patient was in early 2016 the results would be significant.

Alpha, could you publish what this assumption of 248 PFS hitting in say Feb of 2016 and again if instead 248 hit say in June 2016, what would the curves look like in these two cases (which the naysayers seem to believe) and what the resulting SS (p value) would for these two cases. This would be most interesting. Thanx!

[iclight]

The company can unblind the primary endpoint data and release the date 248 PFS was hit and also tell everyone what both IA recs were. No amount of modeling based on other trials control arms matters because those control arms were not being treated by Liau who also said she had hoped there would be clear separation between arms but she wasn't seeing it. Let me know when this study changes from a double blind trial with a control arm back to a P2 without.

There is only one reason they haven't disclosed ANY of that information.

[alphapuppy]

When I get down, as I sometimes do, about this investment especially regarding the tremendous dilution that has occurred and the seemingly never-ending undelivered promises made by management;

It helps me to review some of my own data and modeling curves. I am Awestruck by the PFS survival curves with the long plateau and tail of the curves; And just by looking at these models, which I believe to be accurate and very close to what will be disclosed once the data is finally published, I am calmed down and feel better about this investment.

I thought it might be good to review this again, as there has been nothing disclosed that would invalidate this model data.

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.