Avid Bioservices Inc (CDMO)

[Protector]

sunstar, you are top on. That is indeed the reasoning. The 154 (77+77) were acquired in FULL 100% under the double blinded standard because they evented and only then the IDMC did the look in and hence only then PPHM could unblind them if they decided to stop SUNRISE.

And from the PII Sept 7th 2012 results PPHM know you can get stat sig with 121 (41-40_40) patients on a 113% SOC beating (5.6 vs 12.1 months) while the control arm got Bavituximab. Since the salvaging we know that are REAL performances, the error was not in the calculations of the results the dose switching was a field manipulation that is EMBEDDED in the Sept 7th results. And that is the part SOME would NOT LIKE US TO REALIZE.

The sentence : YES the doses where mixed up, BUT the results were correctly reflecting the clinical trial with mixed up doses in the disadvantage of Bavituximab, hence the results were even better then those of Sept 7th 2012 seems to be hard to swallow for some.

Shan and King EXPLICITLY made statements related to the outperforming of the control arm in SUNRISE and how they pro-actively included that in the design, (text was provide). No doubt at all that the margins are about adding expectation time to the Docetaxel alone.

Docetaxel performed in a very predictable range over many years, ranges that only SLIGHTLY moved based on other care quality AT LEAST the MAXIMUM is well established at 10.4. So PPHM had a VERY GOOD BASIS to start form and to add the margin to in a worst case scenario.

We know Bavituximab has 16+months with patients of this stage/ecog (just like the control arm goes from 5.6 to 10.4 if healthier patients are enrolled. So expecting 14 months is reasonable and allows a 12 months expectation for the control arm. And as you said, the design was to achieve SOC.