Avid Bioservices Inc (CDMO)

[Protector]

golfho, about your 1 patient per 3 months per centre. I simulated it in my model using 1 patient per 90 days per centre. I added a limit of 3 patients per centre (I didn't have a limit) and it gets me 322 patients.

Remember I use the centres PER THEIR opening day, not just 152 and the model is as such that the #days (in this case 90) must be fully available before it counts. So after 85 days my model still counts ZERO patients for that centre. I also use ZERO patients available at opening.

Removing the 3 patients per centre limit does little for the moment because many centres are not open 4 x 90 days (1 year) yet. Furthermore we have seen from the protocols with the centres that we found on the web that 3 may be on the low side in some countries. Under that assumption even Germany would not be able to enrol at 3.07 patients per centre needed. Spain needs 6+ patients (16 centres and 100 patients assigned max).

If we put this parameter to 4 or 5 then with your 90 days simulation it only affect the VERY first centre (the one of DEC 2013) since a few week at 4 and in MAR 2015 at 5. It will make 1 patients difference at this moment. Next would be the 3 centres of JAN 17 2014 and so on. So at 5 the bulk of 33 centres of MAY 29 2014 would only get affected in SEPT 2015 only a few months before the end of enrolment.

We are currently at 30934 enrolment days all centres included, increasing by 152 each day.

So bottom line, your WORST CASE assumption 4 months/120 days per patient per centre with a limit of 3 patients per centre gives currently 238 patients enrolled. And 322 for your second worst simulation of 3 months/90 days.