Avid Bioservices Inc (CDMO)

[jq1234]

>> PPHM would never have received approval for a registrational trial with an open label design like BMY has done with Opdivo IMO.


Of course not when a drug is combined with SOC compared to SOC. It generally requires double blind randomized registration trial. This applies to BMY as well when they conduct such trial. For example, Opdivo in combination with SOC Yervoy compared to SOC Yervoy in this 3-arm melanoma trial - it's double blind:

https://clinicaltrials.gov/ct2/show/NCT01844505?term=Nivolumab&phase=2&rank=3


Single agent drug compared to SOC with completely different dosing schedule is different. For example, Ibrutinib vs Rituxan is open label trial:

https://clinicaltrials.gov/ct2/show/NCT01973387?term=Ibrutinib&phase=2&rank=9

But Ibrutinib in combination with Rituxan and Bendamustine vs Rituxan and Bendamustine is double blind trial:

https://clinicaltrials.gov/ct2/show/NCT01611090?term=Ibrutinib&phase=2&rank=2