NorthWest Biotherapeutics Inc (NWBO)

[Leprecon7777]

Ex,

Using the information you provided as a starting point, and Sentiment’s high-resolution survival chart data; I have derived several possible “tails” that NWBO inexplicably did not provide. Would you mind vetting the analysis and the results? Specifically, I would like for you to confirm my home-brew Excel KM calculations are accurate using your software.

The link provided below provides a spreadsheet with several tabs labeled Data(i), Chart(i). It is not necessary to evaluate all of the data tabs; one will suffice. The tail analysis is based on the following starting conditions:

1) A Survival Curve for the last 44 patients is assumed as a rough starting point.

2) Four events are assumed to have ocurred at 36.5, 40.5, 46.5, and 88.2 months. These survival times were specifically listed as mOS survival times for various sub-groups by the JTM publication; and therefore one can infer that events occurred at these times.

3) Six events occurred after 36 months, based on analysis by others on this board.

4) Some on this board have also theorized that only 1 patient from the original 38 survived past 36 months. This patient is assumed to be the patient that survived for 88.2 months. Additionally, the first 38 patients finished enrolling sometime around June 2012 which only leaves approximately 57 months until March 2017. Thus, the maximum Survival time for all of the patients, excluding the 88.2 month survival, is assumed to be 57 months at the time of the March 2017 analysis.

With these starting conditions, an Excel macro performs the following actions:

1) Randomly assigns each patient a value between 0 and 25.4 which represents the "proportion" on the Kaplan-Meier Curve for the last 44 patients.

2) Assign Survival times of 36.5, 40.5,46.5, and 88.2 months to the first 4 patients.

3) Calculate the Survival time for each of the remaining patients using the assumed Survival Curve.Any patient with a Survival time > 57 months is randomized again.

4) Randomly assign the remaining two events. All other Survival times are censored.

5) Combine the derived tail survival data with the known survival data.

6) Perform the tail analysis to determine if the Survival data meets all of the following criteria:

a) The mOS for all Survival times > 30 months is 46.5 months.
b) The mOS for all Survival times > 36 months is 88.2 months.
c) The mOS for the 100 largest Survival times is 40.5 months.

7) Repeat above actions until the criteria is satisfied (which typically requires hundreds of iterations).

Here is the link:
https://drive.google.com/file/d/1GY9GKPZ6vjsqaZzvD6l63D-tCyiCO8FR/view?usp=sharing

Thanks in advance