Replies to post #596778 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

The comp was to to SOC arms of other trials and clearly has the concerns the FDA expresses

hahahahaha if its a trial data it can not be SOC hahahahahaha

Its EITHER a trial OR SOC cant be both

Ms. Powers, CEO of NW Bio, commented: “We are excited to see the meaningful survival extensions in glioblastoma patients treated with DCVax®-L in this trial – particularly in the “long tail” of the survival curve, where we see more than double the survival rates as with existing standard of care. With well over 400 clinical trials for glioblastoma having failed over the last 15 years, it is gratifying to be able to offer new hope to patients who face this devastating disease.”

Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals. Also called best practice, standard medical care, and standard therapy

SOC data is NOT pre selected trial data

[Dr Bala]

The nonsensical post is an outcome of oblivion to the 2022 paper in the Annals of Oncology by the FDA Oncology Group. Total confusion in the post. The fog in the post can be ameliorated by understanding

a) primarily the 2022 Annals of Oncology paper on the FDA ECA guidance
b) secondarily by understanding the JAMA article
c) tertiarily by reading some basic scientific principles as background to read these articles. This is not Bluebook material.