Avid Bioservices Inc (CDMO)

[bimerkjaere]

I understand the importance of the Stimuvax example as it shows one that just because a trial is lasting longer than expected, this doesn't always equate to longer survival for the treatment arm.

However, I would say Stimuvax's target patient group differs from bavituximab in that Stimuvax’s NSCLC patients had stage III stable disease, with an expected MOS of somewhere between 25 - 33 months. The literature shows significant variance in MOS depending on baseline characteristics (e.g. ECOG score).

With stage III-IV locally advanced or metastatic, untreated NSCLC, you have much lower expected survial times. Carboplatin+paclitaxel in the ECOG trial (2002) showed a MOS of 8.1 months. In the Avastin Phase III trial, C+P control had a MOS of 10.3 months and C+P+Avastin has 12.3 months MOS. Differences in the ECOG C+P and control C+P in Avastin trial could have been attributable to better ECOG PS scores in Avastin trial (40/60) vs. ECOG trial (28/67/5) and a greater % of women in Avastin (50/50) vs. ECOG trial (42/58), as women had longer MOS times in both trials.

Either way, the main point is that bavi’s treatment population in the 1st-line NSCLC trial, is stage IIIB-IV with locally advanced or metastatic disease, a more advanced patient group with lower expected survival times and thus lower chance of variance in MOS output. In other words, this means that the control group is much less likely to produce a much higher MOS than its historical averages. With bavi’s 1st-line trial being extended by multiple months, and using the enrollment completion date of Sept 2011, we are much safer in assuming it is bavi extending the survival compared to the C+P control group (we could be looking at a >18month MOS readout in this trial if reported in Q213) than those investors of Oncothyreon in Stimuvax.

IMO