NorthWest Biotherapeutics Inc (NWBO)

[AVII77]

AVII, do you think 400-500 active users of Optune globally for rGBM and nGBM combined constitutes established SOC?

I would say perhaps. But let's assume the answer is no.


Again, if I may be so bold to predict where you are going with this.....

“Available Therapy” guidelines say the FDA will consider Available Therapies in the context of them being relevant to the “current US standard of care”.

The “new” guidance says: “is relevant to the current U.S. SOC“. It doesn’t say “is US SOC”. IL-2 and carmidene wafers are not “relevant to” current SOC anymore (in melanoma and nGBM respectively). However, Optune, while not yet SOC, is certainly “relevant to current SOC”. It was tested against (and proved survival advantage over) current SOC. Patients in their trial received maintenance temador (current SOC) and Optune’s survival advantage demonstrated superior results over the current SOC. It is definitely “relevant” to current SOC.

The FDA does not want to impede new drug development with the accelerated approval pathway by forcing sponsors to prove benefit against old and outdated “approved” and hence, "available therapies". That is what they mean with that SOC clause. For example; IL-2 was approved in the late 90’s for melanoma. In practice (current SOC) it is no longer widely used in the US (because the therapeutic landscape in melanoma has changed dramatically). IL-2 is “approved or licensed” but it is no longer “relevant” to the current US SOC. Similarly, Carmidine Wafers are “approved” for nGBM patients but I have little doubt that the FDA would not deny AA to DCVax-L because patients in the trial didn’t receive them. They are not very “relevant” to the US SOC anymore (largely replaced by the Stupp Protocol).

Again, did I guess correctly where you were going with that question?