Avid Bioservices Inc (CDMO)

[nuke661]

BioBs,

Thank you for the information. It has raised some questions that I would appreciate anyone's opinion on. First, from the clinical trials gov website for this trial the following is obtained:

Bavi Sorafenib trial info

Patients must be Child-Pugh A with no previous treatment with sorafenib or other vascular endothelial growth factor (VEGF) inhibitors.

From Wikipedia the following info is provided regarding Child-Pugh scoring:

Wiki Child-Pugh Info

Interpretation 
  
 Chronic liver disease is classified into Child-Pugh class A to C, 
 employing the added score from above.[1] 
 Points 	Class 	One year survival 	Two year survival 
 5-6 	           A 	100% 	                      85% 
 7-9 	           B 	81% 	                      57% 
 10-15 	           C 	45% 	                      35%

Something doesn't seem to add up here. We know that the trial was only supposed to have Child-Pugh A patients and therefore the 6 volunteers whose OS and biopsy data is being discussed should have have been Child-Pugh A and have a 100% chance for 1 year survival but the OS data for all 6 was not even close to 1 year.

First question is, am I correct in how I am trying to assess the expectation of survival for our 6 volunteers based on the requirements of the trial inclusion criteria and what OS is expected based on Child-Pugh scoring?

2nd, does anyone know if it is allowable by FDA regs to take patients into a trial with a Child-Pugh score worse than the scoring criteria specified in the criteria posted in the clinical trials.gov website?

Thanks in advance for any input on this.