Avid Bioservices Inc (CDMO)

[co3aii]

When a new drug is used in combination with an approved SOC drug the Phase III is more complicated because one of the arms for the trial must be the SOC by itself as a control. If the drug was being trialed by itself it would be versus placebo but in order to correct for the effect of the SOC PPHM will have to run an arm for the SOC by itself. One of the reasons that all companies who combine drugs go slow is that this additional arm costs a small fortune, as you are in effect doubling the participants and you had better get it right and not credit your drug with results from the SOC.