Avid Bioservices Inc (CDMO)

[Protector]

jq, I figure that with drop outs you mean censored patients?

I did indeed NOT include them in my last post. The reason is very simple, I did NOT say anything about the 3mg/Kg Bavituximab arm and only looked at the CTRL arm results.

There will for sure be censored patients BUT there also was a consensus on the board that in the PII 2nd ln NSCLC their number was quite high. PPHM has pointed out there were difficulties with keeping track of patients in Eastern-Europe (I think Ukraine was mentioned explicitly).

In the CTRL arm there SHOULD be less censored patients because Doce patients will event according Herbst et al. 2010 scenario. In the Bavi arm however we may have higher number of survivals at end of trial (582*0.80 events). Such survivors are automatically censored too. We have no good data about that, that I know of, on the PII.

Also remember that the FIRST patients where US and Western Europe (those centres opened till and including JUN 2014). You will have VERY FEW drop-outs due to loosing the patients whereabouts and not showing up any more in those countries. In the US/Europe Insurance and Social Security allows patients to finish treatments they started.

But drop-outs would not play a big role here. TODAY we are at about 139 events for the CTRL arm and 154 needed for 1st look-in. That means we don't have 15 events from the Bavi arm. Hence 139 vs 15 worst case.

Now just assume 10% drop outs. Then we would have 125 CTRL events and 29 events NOT delivered by the Bavi arm. So the worst case here is still 125 vs 29.