InvestorsHub Logo
icon url

BioBS2012

08/04/14 11:20 AM

#185187 RE: edcpf #185184

I'm guessing we have about 200 patients already.eom



Here are my projections FWIW (based on the assumptions therein)

The table below shows the ESTIMATED number of patients that would event based on the following assumptions:
1) # of sites at 121 as of July-end 2014.
2) No new sites added from here on out
3) Enrollments begins 3 months after site opening - e.g. for a site that open in January,2014, the first patient would only be enrolled in April, 2014 - so if 5 sites opened in January, there would be 5 patients enrolled in April
4) After initial enrollment, additional patients would enroll at the rate of 1 patient every two months (column 0.5 - 0.5/month enrollment) OR 1 patient every 4 months (column 0.25 - 0.25/month enrollment)
5) SOC MOS assumed at 7 months - meaning if 5 patients enolled in April and 2.5 got SOC, then 7-months later 1.25 would have evented (November). BAVI MOS assumed to be conservatively 60% higher then SOC MOS
Ofcourse life is never linear nor as straightforward as these assumptions, but based on the above assumptions, we would have 115 patients evented by June 2015 if enrollment rate is one patient every two-months, and 82 patients evented if enrollment rate is 1 patient every 4-months.
0.5 0.25
Month Events Events Month
2014 January January
Feb. Feb.
March March
April April
May May
June June
July July
August 0.00 0.00 August
Sept. 0.00 0.00 Sept.
October 2.03 2.03 October
Nov. 4.06 4.06 Nov.
Dec. 7.11 6.60 Dec.
2015 January 13.20 11.68 January
Feb. 30.47 27.42 Feb.
March 48.14 42.55 March
April 72.52 60.84 April
May 91.00 70.08 May
June 115.58 82.37 June
July 140.16 94.66 July
August 164.73 106.95 August
Sept. 189.31 119.23 Sept.
October 213.89 131.52 October
Nov. 238.47 143.81 Nov.
Dec. 263.05 156.10 Dec.


Here is the Enrollment Estimates Corresponding to the above table
0.5 0.25
Month Enroll Enroll Month
2014 January 0.0 0.0 January
Feb. 0.0 0.0 Feb.
March 0.0 0.0 March
April 5.0 5.0 April
May 10.0 10.0 May
June 17.5 16.3 June
July 32.5 28.8 July
August 75.0 67.5 August
Sept. 118.5 104.8 Sept.
October 178.5 149.8 October
Nov. 224.0 172.5 Nov.
Dec. 284.5 202.8 Dec.
2015 January 345.0 233.0 January
Feb. 405.5 263.3 Feb.
March 466.0 293.5 March
April 526.5 323.8 April
May 587.0 354.0 May
June 647.5 384.3 June
July 414.5 July
August 444.8 August
Sept. 475.0 Sept.
October 505.3 October
Nov. 535.5 Nov.
Dec. 565.8 Dec.


If you plot these they really do look like lovely HOCKEY-STICKS wink


icon url

spankyvol

08/04/14 5:46 PM

#185249 RE: edcpf #185184

I'm guessing 36 enrolled patients.