NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Now that we know for certain that the FDA accepts, and has endorsed the use of External Control Arms (ECAs) as a preferred tool to be used, to augment the control group in a clinical trial, when a Phase III clinical trial has a high percent of control patients, who crossover to take the treatment that is being studied (DCVax-L):

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165904723


We can look at the DCVax-L revised SAP and revised endpoints in a new light. The revised DCVax-L trial Primary Endpoint requires the use of 3 different analysis to determine if the Primary Endpoint has been met.

We can also look at the slide that Dr. Linda Liau presented several months ago, again in a new light.

I love the title of Dr. Liau's slide:

Statistical Analysis Plan (SAP) for RCT (Randomized Controlled Trial) With Cross-Over Arm

Because of Dr. Liau's slide, now we know what the 3 different analyses are that will be used to determine if the DCVax-L trial met its Primary Endpoint:

Analysis 1: Cox Proportional Harzards

Analysis 2: Conditional Survival

Analysis 3: Subgroups, Cox PH

We also now know what analysis will be used to determine if DCVax-L also met its first Secondary Endpoint, so it can also be approved to treat recurrent GBM:

Analysis 1: Cox Propotional Hazards

What recently completed Phase III randomized controlled trial (RCT) are we aware of, that had a cross-over arm and the Primary Endpoint is overall survival (OS) compared to external control arms (ECAs), and the first Secondary Endpoint is to compare the OS for recurrence to ECAs?

Dr. Liau is practically telegraphing that all roads lead to "YES" and to "Evidence of Benefit"