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# Celsion Corp. Message Board

• daviscupper daviscupper Nov 21, 2012 10:02 AM Flag

## 12 months vs. 56 months are stellar results.

From the publicly available patient enrollment data, time in trial, know number of PFS events and the well established historical record for the control arm patients to have a 12 month median PFS rate the following results can be deduced:

If control is 12 months, then results are: 12 vs 56.
12 months = 290 PFS events
56 months = 90 PFS events
Total = 380 PFS events

If control is 15 months, then results are: 15 vs 52
15 months = 283 PFS events
52 months = 87 PFS events
Total = 380 events

If control is 18 months, then results are: 18 vs 34
18 months = 239 PFS events
34 months = 141 PFS events
Total = 380 events

Some have suggested results are 15 vs 25
15 months = 283 PFS events
25 months = 189 PFS events
Total = 472 events 380 events, not possible.

Taking CEO Michael Tardugno's long held position that the control arm has a 12 month median PFS rate indicates that the results are going to "rock" the medical world. This is probably why he has used the terms "possible cure" in his last two presentations. Cheers and GLTA longs.

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• I don't think you understand what median survival is. To reach 56 months of median survival you need half of the 350 patients in the trial arm which is 175 patients to survive 56 months. 175 patients in the trial arm were not even enrolled until 8/3/2010 and even if every single one of them survived 56 months that would put the survival date sometime in 2015.

Here's my guestimate based on 12 months and 16 months and your enrollment data.

12 month expected median for control group according to Celsion
16 month median needed for trial group to pass 33%.

4 months = 1 Standard Deviation for both groups. This is a guestimate

68% of control group last 8 to 16 months which is within one SD.
16% last less than 8 months. 16% last more than 16 months.
84% of control last 16 months.

68% of trial group needs to last 12 to 20 months which is within one SD.
16% last less than 12 months. 16% last more than 20 months.
50% of trial last 16 months.

So using 16 months as common end date and assuming control and trial groups are enrolled evenly over time.

(84% + 50%) / 2 = 67% of total enrolled need to last 16 months.

To reach 380 events for both groups you need to enroll 567 patients and wait 16 months.

567 patients were enrolled somewhere between 5/12/2011 and 8/5/2011.

16 months after those dates are 9/12/2012 and 12/5/2012 for 380 pfs events.

It is going to be close I believe. Each additional month the control and patient group survives pushes out the time range by a month.

• dc, if the current time lag (28 mnth) between x enrollees and x events is maintained, 12v56 is impossible. That would suggest a median trial pfs of 36 mnths, which is greater than the 30 months it took for 380 events to be achieved after enrolling 380 patients. Now, on the other hand, you may be on to something, if the rate of time lag change is maintained -that is to say, the time lag between 500 enrollees and 500 eventees becomes 36 months, and then 700 enrollees/eventees becomes say 45 months, etc.

I think 15v25 is about right. We fail only if control is 20 months.

• Davis, last post on this. Stop spamming all boards and social media with this. Your math only works with specific assumptions (i.e. all have evented by 36 months or so) and is NOT how the actual medians are calculated (look up Kaplan-Meier).

Over the top predictions do not help anyone.

• Trond,

A 12 month median PFS rate for the control group is not my number. It is the number our CEO has been touting for the last 6 years. It is a number based on historical clinical trial records. It is a number that our Chief Medical officer uses after consulting with the collective wisdom of the world's leading KOLs.

I used that number, published patient enrollment data, time in trial data and the 380 PFS event number to perform straight forward mathematical calculations. The results are amazing. 12 vs 56 is the result. Yes, the results are fantastic and that is probably why our CEO is talking about a cure!

12 vs 56 is what is being forecasted and more and more people will do similar calculations and get similar results. Things look great going foreword.

Also, a 36 month tail is entirely reasonable for the control. The median PFS rate is 12 months. This corresponds to a 30 month OS rate for the same group. After 60 months 92% of these patients are dead. That corresponds to 24 months in the PFS rate. I added another 12 months to pick up the remaining 8% of patients to have a PFS event. After 36 months it is entirely reasonable to assume that 99% plus of the control patients have had an event.

Regarding Kaplan-Meier, that is a likelihood estimator of the true median. My model is also attempting to estimate the true median. I don't use the Kaplan-Meier method because it entails using a sequential, reiterating compounding probability calculation for every month patients event. Such detailed data is only available to the DMC. As mentioned above I used publicly available patient enrollment dates, time in trial, known number of PFS events and dates, and the well documented 12 month PFS rate for control. The results are amazing:
12 vs 56.