I assume you’re referencing that her reference to an SAP with a primary endpoint of survival based on external controls can be correlated to benefit and thus ‘successful’. Clearly it represents Northwest’s new SAP. Anything else to be gleaned from this for us non-medical background folk?
Thank you Nick119, i was glad to see the slide below because Dr. Linda Liau basically telegraphed and laid out how the the DCVax-L clinical trial data, and revised Primary Endpoint in the revised SAP will be analyzed.
According to the revised SAP, the new Primary Endpoint is as follows:
compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma. This endpoint will be assessed using 3 different analyses
Because of Dr. Liau's slide tonight, now we know what the 3 different analyses are:
"..and it seems a shame that each time we have to do a large phase 3 trial we have to enroll several hundreds of more patients into these control arms, so over the next 10 years we will have another thousand patients in control arms just to prove that your new therapeutic actually works.."
Anytime we bring our hands in toward our heart or chest, we usually want to indicate to ourself. Looking down and to the right can indicate that the person speaking is attending to internal emotions.