Avid Bioservices Inc (CDMO)

[Protector]

PPHM 2nd ln NSCLC SUNRISE Update

Date of Post

 
 Currently Opened Centres           133        From US filings 
 Surely Remaining Centres            34        From European filings 
 Temporary Total                    167 
 Initially announced Centres        150        Statement CC/Shan 
 Total Estimated Centres            175-200    Ukraine/Singapore 
  
  
 Patients per day needed           0.79        To enrol 582 per DEC 2015 
 Patients to be On Track Today      191        Since DEC 30th, 2013 
 Patients Enrolled According SIMUL  190        Used 0.5 pat/cent/month 
 

PS: PPHM needs to enrol 0.79 patients per day on average to enrol 582 patients at the target date for end of enrolment DEC 2015. Today that would result in the above On Track data. It is a LINEAR worst case assumption, assuming they NEVER get ahead of schedule and a LINEAR best case assumption, assuming they never get behind schedule and so stay On Track according Shang's used terminology. With the hockey stick we know that isn't the case but the daily need remains because it is ON AVERAGE.

It would mean we had 120 patients in MAY 2014 if Shan's statement was accurate and linear while the simulation only projected 34 patients end MAY 2014, moment at which 33 centres were added at once. This shows that the simulation is VERY conservative (it will catch up as of Aug 30th 2014) and is not linear (as it takes into account the precise date now that the centres where opened).

It does not take into account individual centres when more then 1 was opened the same day, hence there is no adjustment for centres recruiting more SIMULATED patients then their assigned number (European Protocol). This will introduce a margin of error as of the moment a centre, or a country, should have reached its maximum assigned number of patients.

In this simulation that would be 6 to 8 months after opening for most European centres that may recruit an average of 3.xx patients per centre and 12-14 months for Spain who is an exception. I will not comment on Greece as I thing the protocol contains errors (120 patients for 9 centres seems odd. However if that were correct the error will be minimized because at 0.5 simulated patients enrolled per month their error will only show after 24 months which would be behind DEC 2015.

For the US+World of which we have no detailed information on patient assignment per country except 582-345=237 in total the average is just not 4 patients per centre. So there is also an 8 month delay on possible errors and that will start weighting at the end of this year.


So I am quite confident in the simulation to be not to far off until MAR-JUN 2015 given the paste at which centres were added in the different regions of the world.

I may have found an indirect way to fine tune as I was told import/export of controlled substances (Bavituximab is one such substance) is public record in some countries. I would then assume that PPHM doesn't send out Bavituximab to places where there are no patients to treat. Using an average weight, for those Stage III and IV quite sick patients of 55Kg body weight and assuming 50% is randomized into placebo, we may be able to tune more if PPHM doesn't give us updates. I'll see if I can find public records but that isn't really my cup of tea.