Avid Bioservices Inc (CDMO)

[Protector]

cjaddy, thanks. A blooper in Garnick's Q/CC Q & A.

9-8-16/CC: ROBERT GARNICK (Head of Reg. Affairs):
I’d like to emphasize the strategic importance of the biomarker study, which, as Joe said, was built into the SUNRISE trial. The identification of a positive biomarker or relevant biomarker pattern with clinical efficacy is an important facet of clinical trial design that can be used to inform addl. new studies that in turn might be used to select patients who would best benefit from bavituximab therapy. For example, the identification of the HER2 biomarker was critical in the development of Herceptin. Its importance was only critically established based on the results of a Phase II clinical trial. As Steve previously described, the critical role of the PD-L1 biomarker is emerging as a major factor in the selection of patients for the clinical use of Opdivo & Keytruda. In the case of bavituximab, once a promising biomarker or biomarker pattern is identified, we strategically plan to include these results into potential new clinical trials...

Garnick gives away that they have identified a promising biomarker or biomarker pattern indirectly by the red coloured phrase. He probably didn't know that there would be an analyst question in the Q & A, AFTER he said the above, to which CEO King would answer that PPHM's involvement in the NCCN clinical trials was limited to delivering bavituximab AND TO CONSULTANCY RELATED TO INCLUDE THE BIOMARKER INTO THE 3 NCCN CLINICAL TRIAL DESIGNS.

I think logic dictates that you cannot do such inclusion if you don't have a working biomarker and either CEO King lies and they are NOT including biomarkers in these trials or they do indeed include them and hence have the biomarker. It is the second option of course because CEO King would never INVENT that they provide consultancy if they don't. Why would he?

And Garnick says EXPLICITLY that they would only do it if they HAVE identified a promising biomarker or biomarker pattern. As a consequence...