Avid Bioservices Inc (CDMO)

[mskatiescarletohara]

Actually, I think SK and Thorpe are more involved here than we think. I know for a fact Thorpe was frustrated with the FDA process just in getting Phase I approved.

Given the company's current clinical status i.e. cancer Phase I, and HCV repeat dose, they had to make a decision to move forward. India provides that outlet, my only concern about India is I worry this crowd will partner with some unknown, wannabee a CRO too in the very rapidly growing CRO/pharma market there. That's all. Who's going to fly to India and make sure the protocol is being audited? Is PPHM going to hire an outsider in India to check on the CRO and make sure proper consent is given, doses etc. Is the facility FDA inspected, if it works is this a company they can continue to do business with, have they had success with the EMEA...

I hope Bavi works, the pre-clinical data is compelling, although will the similar safety profile remain the same as achieved in Phase Ia....we don't know. The safe harbor statements have changed, now that the combo study is advancing. Will increasing chemo uptake increase side effects, can it be dosed without any SAEs? We shall see.

katie....