Replies to post #283849 on Avid Bioservices Inc (CDMO)

[vinmantoo]

The objective is to get to PIII, run your trial and get approval for commercial sales. They presented all data to FDA and were approves for a PIII trial with 582 patients. Do you think they should have said no, we'll run another PII?? Not too hard to figure out!!

Were you joking? I sure hope so. The goal it to get through a phase III with the highest probability for success you can have. Rushing headlong into phase III without solid supportive phase II data in terms of most efficacious dosage of your drug, best administration regimen and best drug combo. Without that foundation only careless, reckless amateurs go into a large phase III trial.