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alphapuppy
Dropbox file expired. Can you repost please? Thank you for your due diligence on this.
The leakage problem is real. I know a company where its stock price doubled in 6 months and later I found out that is precisely the period in which the company hit the streets for sale (presumably discreetly).
So the run up in KITE since May was likely during the due diligence period of Gilead.
You wrote:
"Seems like there is still a lot of confusion on the board regarding median OS."
Yes there is.
You wrote:
"Let's start with the basics. When the trial reads out, is the reported mOS based on the group of actual patient events (say median of the 233 recorded events if unblinded then), or is it the estimated median survival of the entire trial group of 331 (so the 165/166 rankings) with the KM technique applied to account for events that have not actually occurred or been recorded (LTFU, etc.,)?
I am not sure how they account for the living patients but if the hypothetical you state below is carried out, the the MEDIAN WILL IMPROVE (Example given below).
You wrote:
"If it is the latter, and the remaining patients alive have all exceeded the survival time of the current 165/166 events in rank order, then shouldn't the median remain static going forward as additional events would be plotted to the right of 166 on the curve all the way out to 331?"
NO. The median will not remain static if the remaining patients are included and if there survival times exceed those of the deceased. Here is a simple example:
say that there are 5 deceased patients with survival times:
1 month
2 months
3 months
4 months
5 months
median is therefore 3 months
If a living patient (whose longevity already exceeds the 3 month mark)-is ADDED to the pile, that would place them in the rank order somehwere after the 3 months (let say the living patient was alive for 4.5 months at the time of the trial unblinding); Then,
1
2
3
4
4.5
5
would be the new rank order and the median is now between 3 and 4 (or precisely 3.5).
Go read eagle8 post #131659--he summed it well.
T.
You are correct, two medians needed (control and drug). I was so focused on illustrating the median that I missed that key point. Good catch! Thanks.
As to your question,
If a new event falls to the left of the median, it shifts median to the left.
Example: (bold is the new event)
1
2
3
4
5
median is 3
add new event to the left of median
1
2
2.5
3
4
5
median is between 2.5 and 3 (i.e. 2.75)
If a new event falls to the right of the median, it shifts median to the right
Example: (bold is the new event)
1
2
3
4
5
median is 3
add new event to the right of median
1
2
3
3.5
4
5
median is between 3 and 3.5 (i.e. 3.25)
I think there is an easier explanation for the mOS than has been offered to date.
If NWBO stops the trial at precisely 233 OS events, the median will be the 117th patient (when all the deceased patients are rank ordered by how long they lived). If NWBO waits unitl 234 OS events, then the median will be the average of the 117th patient and the 118th patient. If they wait for 235 OS events, the median will be the 118th patient, and so on.
So, Senti and others are correct that the more OS events that occur the more the mOS shifts to the next patient---these differences may be small but that is how medians work in this case.
No effect on the share price as neither trial started. When they do start (and if) then there should be some small pop in share price. I would admit for the actual start of a trial the bump would be very small--that is why they should be coalesced with the other events (i.e. paper and topline results) for maximum punch.
Clearly topline results will have the biggest impact. The paper being second in impact IMHO.
The "INFLECTION POINT" for the company according to Les were 4 things:
1. The end of the trial (i.e. release of topline results)
2. The scientific paper
3. The start of the UCLA trial (which we now see is scheduled)
4. The start of a Germany trial
If I were advising them I would want these events to coalesce into a very short window of time--perhaps even a single PR or presentation (or both) for maximum impact.
Because of their low cash position, these have to happen (IMHO) sooner rather than later. Sooner being within the next few months.
Obviously, I am hoping for good news on all fronts. If so, i could believe a $10B evaluation or about $22 per share---I'll take that!
GLTA
When Les told me, 'he could not disclose that [i.e. whether the company would report out when they hit 233 OS events or was it the intent to run the trial beyond the 233 events] to me as an individual and that such information would have to be reported more broadly to all investors", I dont know whether that meant a formal 8Q was needed or whether a public disclosure such as a presentation would satisfy his obligations.
Experience--then please offer up an explanation as to why members of the NWBO management team, who presumably know more than you or I, put up money as recently as a few months ago? Is that to give institutional investors a a chance to unload to retail?--give me a break! I'll wait to hear your analysis of management behavior on major loans to the company.
Senti
Nice post.
Could it also be that the FDA hold on enrollment was related to the early appearance of progression from DCVax?
Flipper
I am sure you are right that no one is calling NWBO and asking for deaths to be sped up. My earlier post stated;
"He did remark how he was amazed at the shareholders who have called him essentially asking that the company 'speed up the deaths' to get to the 233!"
The operative word above is ESSENTIALLY. It was not meant to be literal. Les did not say, nor did I intend to imply that people LITERALLY asked NWBO to speed up deaths. The point he was making (I believe) was that he has been surprised how disappointed people have been that the 233 events have not occurred. Anyone disappointed or frustrated that 233 events have not occurred yet is effectively ('essentially') saying they want the deaths sped up. Nobody want the deaths sped up and yet we all want the trial to be over in order to get results reported. See the irony in that?
As to the $$--I have no idea whether they have enough $ or not for the next few months--Les said they did based on a low burn rate of $1M per month--which I don't know if that low burn rate is true. If these facts are untrue, then he lied. But I hope not.
Hope this clarifies
Bio-addict,
Your summary of my call is accurate. I took away from the call that they will get to the un-blinding with the money they have and that will occur within the next 5 months--either because they have not hit 233 or because they are electing to wait more. Also, within that time, Les said they should finally get the paper out (I presume he meant published) and they should get the UCLA and Germany trials underway too. I hope he is correct on all fronts but of course I don't know that he is.
Let me restate what I was told and respond to posts at the same time. It is ironic that flipper44 would be the one that thinks I misinterpreted Les as flipper44 was my motivation to call Les. A few weeks ago flipper44 stated he would call Les and then suddenly said he changed his mind. I did ask Les what the intent was after they hit 233--were they going to let us know right away or is it their plan to let the long tail run a bit more. Kabanushi pointed out that perhaps my conversation was naïve on my part--if so, I accept that--but that is what I asked. I guess that many would not be surprised that Les did not answer the question.
Les did volunteer that the burn rate had been reduced to $1M per month and that they had the money to carry them for the next 5 months (and he referenced the 10q--but I see only $22K in cash) and that should get them to the "inflection point" which he said included the end of trial (presumably 233), the paper, the trial at UCLA and a trial in Germany. Exwannabe said that Les "bald faced lied"--perhaps he did--you decide--but that is what Les said.
Turtle65: thanks for trusting me that I made the call. I have actually spoken to Les 2 other times before but that was 2+ years ago. I have 2 friends that are shareholders (who got me into this) and together we have called Les about 7 times in total and he always takes the call (or calls you back). We have found him to be credible but that is just our opinion--we really don't know for sure what to believe sometimes.
ex,
I got a bit bleary-eyed reading the 10Q--help me out---what can be concluded about how many months (or days) the company has in cash at a burn rate of $1M per month?
I spoke with Les Goldman today. I asked whether he would confirm that the company would report out when they hit 233 OS events or was it the intent to run the trial beyond the 233 events (as some on this board have speculated). I thought he could tell me their intent as I was not asking if they hit 233, but whether they plan on telling us promptly once they do.
You would be right if you guessed that he said he could not disclose that to me as an individual and that such information would have to be reported more broadly to all investors.
He did remark how he was amazed at the shareholders who have called him essentially asking that the company 'speed up the deaths' to get to the 233! He made the obvious comment that patients are living longer and that is only good news. He did not say this directly BUT it sounded like they had not hit 233 OS events yet!
At any rate, he volunteered that if I read the 10Q carefully I would see that they have cash for about 5 months at a burn rate of $1M a month (Les said they brought their burn rate down to $1M per month). He made the point that in the next 5 months he thought that was sufficient to end the trial, start the UCLA and Germany trials and complete the publishing of their paper--he referred to these collective events as an inflection point for the company.
He was very cordial and professional. I found him to be credible.
Holding LONG with 80,000 shares at a $1.52 average.
Good Luck to All
Doc,
I did previously post (#120559) a digitized version of Dr Boschs enrollment chart but no one ran with the data (I can not analyze effectively).
Perhaps this is useful for you.
Here was the prior post content:
A= month
B-= % enrolled
C-= Total # of patients enrolled
D-= Total # of DC patients enrolled
E-= Total # of placebo patients enrolled
A B C D E
1 oct '08 2 6 4 2
2 nov '08
3 dec '08 3 10 7 3
4 jan '09
5 feb '09 4 13 9 4
6 mar '09
7 apr '09 15 10 5
8 may '09
9 jun '09 5 17 11 6
10 jul '09
11 aug '09
12 sep '09
13 oct '09
14 nov '09
15 dec '09
16 jan '10
17 feb '10
18 mar '10
19 apr '10
20 may '10
21 jun '10
22 jul '10
23 aug '10
24 sep '10
25 oct '10
26 nov '10
27 dec '10
28 jan '11
29 feb '11
30 mar '11
31 apr '11
32 may '11
33 jun '11
34 jul '11
35 aug '11
36 sep '11
37 oct '11 5 17 11 6
38 nov '11
39 dec '11 22 15 7
40 jan '12
41 feb '12 8 26 17 9
42 mar '12
43 apr '12 31 21 10
44 may '12
45 jun '12 11 36 24 12
46 jul '12
47 aug '12 45 30 15
48 sep '12
49 oct '12 16 53 36 17
50 nov '12
51 dec '12 63 42 21
52 jan '13
53 feb '13 22 73 49 24
54 mar '13
55 apr '13 79 53 26
56 may '13
57 jun '13 26 86 58 28
58 jul '13
59 aug '13 101 68 33
60 sep '13
61 oct '13 35 116 78 38
62 nov '13
63 dec '13 129 86 43
64 jan '14
65 feb '14 43 142 95 47
66 mar '14
67 apr '14
68 may '14 50 165 111 54
69 jun '14 52 172 115 57
70 jul '14
71 aug '14 187 125 62
72 sep '14
73 oct '14 61 202 135 67
74 nov '14
75 dec '14 220 147 73
76 jan '15
77 feb '15 72 238 159 79
78 mar '15
79 apr '15 253 170 83
80 may '15
81 jun '15 81 268 180 88
82 jul '15
83 aug '15 293 196 97
84 sep '15
85 oct '15 96 318 213 105
86 nov '15 100 331 222 109
87 dec '15
88 jan '16
89 feb '16
90 mar '16
91 apr '16
92 may '16
93 jun '16
94 jul '16
95 aug '16
96 sep '16
97 oct '16
98 nov '16
99 dec '16
100 jan '17
101 feb '17
102 mar '17
103 apr '17
104 may '17
105 jun '17
106 jul '17
107 aug '17
Here is some more granularity in the enrollment data. I did some interpolation between the points I pulled off the enrollment graph.
A= month
B-= % enrolled
C-= Total # of patients enrolled
D-= Total # of DC patients enrolled
E-= Total # of placebo patients enrolled
A B C D E
1 oct '08 2 6 4 2
2 nov '08
3 dec '08 3 10 7 3
4 jan '09
5 feb '09 4 13 9 4
6 mar '09
7 apr '09 15 10 5
8 may '09
9 jun '09 5 17 11 6
10 jul '09
11 aug '09
12 sep '09
13 oct '09
14 nov '09
15 dec '09
16 jan '10
17 feb '10
18 mar '10
19 apr '10
20 may '10
21 jun '10
22 jul '10
23 aug '10
24 sep '10
25 oct '10
26 nov '10
27 dec '10
28 jan '11
29 feb '11
30 mar '11
31 apr '11
32 may '11
33 jun '11
34 jul '11
35 aug '11
36 sep '11
37 oct '11 5 17 11 6
38 nov '11
39 dec '11 22 15 7
40 jan '12
41 feb '12 8 26 17 9
42 mar '12
43 apr '12 31 21 10
44 may '12
45 jun '12 11 36 24 12
46 jul '12
47 aug '12 45 30 15
48 sep '12
49 oct '12 16 53 36 17
50 nov '12
51 dec '12 63 42 21
52 jan '13
53 feb '13 22 73 49 24
54 mar '13
55 apr '13 79 53 26
56 may '13
57 jun '13 26 86 58 28
58 jul '13
59 aug '13 101 68 33
60 sep '13
61 oct '13 35 116 78 38
62 nov '13
63 dec '13 129 86 43
64 jan '14
65 feb '14 43 142 95 47
66 mar '14
67 apr '14
68 may '14 50 165 111 54
69 jun '14 52 172 115 57
70 jul '14
71 aug '14 187 125 62
72 sep '14
73 oct '14 61 202 135 67
74 nov '14
75 dec '14 220 147 73
76 jan '15
77 feb '15 72 238 159 79
78 mar '15
79 apr '15 253 170 83
80 may '15
81 jun '15 81 268 180 88
82 jul '15
83 aug '15 293 196 97
84 sep '15
85 oct '15 96 318 213 105
86 nov '15 100 331 222 109
87 dec '15
88 jan '16
89 feb '16
90 mar '16
91 apr '16
92 may '16
93 jun '16
94 jul '16
95 aug '16
96 sep '16
97 oct '16
98 nov '16
99 dec '16
100 jan '17
101 feb '17
102 mar '17
103 apr '17
104 may '17
105 jun '17
106 jul '17
107 aug '17
flip--good catch
OK--let me try again.
Here are the data that I digitized from Dr Bosch's graph on enrollment.
Can someone make some projections with this? (I am not smart enough)
approx 2% (6 patients) enrolled by Oct '08
approx 4% (13 patients) enrolled by Feb '09
approx 5% (17 patients) enrolled by Oct '11
approx 8% (26 patients) enrolled by Feb '12
approx 11% (36 patients) enrolled by Jun '12
approx 16% (53 patients) enrolled by Oct '12
approx 22% (73 patients) enrolled by Feb '13
approx 26% (86 patients) enrolled by Jun '13
approx 35% (116 patients) enrolled by Oct '13
approx 43% (142 patients) enrolled by Feb '14
approx 50% (165 patients) enrolled by May '14
approx 52% (172 patients) enrolled by Jun '14
approx 61% (202 patients) enrolled by Oct '14
approx 72% (238 patients) enrolled by Feb '15
approx 81% (268 patients) enrolled by Jun '15
approx 96% (318 patients) enrolled by Oct '15
100% by Nov'15
Note: ALL errors are my own--did my best
Here are the data that I digitized from Dr Bosch's graph on enrollment.
Can someone may some projections with this? (I am not smart enough)
approx 2% (6 patients) enrolled by Oct '08
approx 4% (13 patients) enrolled by Feb '09
approx 5% (17 patients) enrolled by Oct '11
approx 8% (26 patients) enrolled by Feb '12
approx 11% (36 patients) enrolled by Jun '12
approx 16% (53 patients) enrolled by Oct '12
approx 22% (73 patients) enrolled by Feb '13
approx 26% (86 patients) enrolled by Jun '13
approx 35% (116 patients) enrolled by Oct '13
approx 43% (142 patients) enrolled by Feb '14
approx 50% (165 patients) enrolled by May '14
approx 52% (172 patients) enrolled by Jun '14
approx 61% (202 patients) enrolled by Oct '14
approx 72% (238 patients) enrolled by Feb '15
approx 81% (268 patients) enrolled by Jun '15
approx 96% (268 patients) enrolled by Oct '15
100% by Nov'15
Note: ALL errors are my own--did my best
Flip,
been following the board for 3 years+
you have the best posts.
thanks for you unrelenting diligence.
B.
thanks for the fast and informed reply
Baranuk,
I am hoping that between you, Flip, Senti, and others that you will rework the models that you have been diligently putting together and provide the best and latest estimate of trial results. I believe you know that the end result is good--but is it great?
If Woody is all sold out, then that may be 2 mistakes he made--1. getting in too high 2. getting out too low.
Almost feel sorry for him---well, almost
pgsd,
The countdown clock reeks of calling attention to themselves.
I have a hard time imagining why they would spend big$$ on the theater and then present a countdown clock on their website if their update was insignificant. GO LONGS!
Diamondjim,
Love the confidence in NWBO!