Replies to post #54466 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I completely disagree. Ask highwayman if even a thousand active headsets globally even comes close to constituting SOC when in the U.S. alone there are 18,000 cases.

Also, I disagree with your conclusion regarding how they determine available therapy. Instead:

FDA’s available therapy determination generally focuses on treatment options that reflect the current SOC for the specific indication (including the disease stage) for which a product is being developed. In evaluating the current SOC, FDA considers recommendations by authoritative scientific bodies (e.g., National Comprehensive Cancer Network, American Academy of Neurology) based on clinical evidence and other reliable information that reflects current clinical practice. When a drug development program targets a subset of a broader disease population (e.g., a subset identified by a genetic mutation), the SOC for the broader population, if there is one, generally is considered available therapy for the subset, unless there is evidence that the SOC is less effective in the subset. -- FDA

[Doc logic]

AVII77,

With regard to Optune, patient acceptance and quality of life considerations seem to be holding up its relevance to SOC. It seems to be an option but not necessarily an option that should be considered SOC, at least at this point, as many patients would perhaps opt out. This would seem to be a consideration FDA would weigh carefully with regard to possible alternate treatments with equal comparative benefit and better quality of life with regard to SOC as it currently exists. I'm pretty sure this would come up in their discussions don't you think?