NorthWest Biotherapeutics Inc (NWBO)

[Umibe5690]

I am talking about blanket regulatory approval as opposed to some type of limited approval. Obviously, the vaccine may not work on everyone at least to the same extent. GBM is a very personal disease and it varies from patient to patient. There is no such thing as a 100% MES or pro-neural, etc. GBM tumour(s). It is very heterogenous as well as mutative. Accordingly, Dr. Ashkans, the lead PI for the UK(and Europe, I believe), stated quite clearly that the vaccine should be made available to all ndGBM patients as the vaccine may work to a greater or lesser extent across the entire ndGBM spectrum.

For example, Optune was given blanket approval. There was no showing that TTF works to the same extent across the ndGBM spectrum. If DC VAX L works across a broad spectrum such as M+ and MES which together may comprise over 60% of all ndGBM, I believe that the FDA will grant blanket approval just as it did for Optune.

You are correct that the vaccine may not work in a number of individual cases. However, whether to use the vaccine or not as an adjuvant therapy, should be a decision left to the patient and his physician rather than to regulatory fiat, especially if the results show wide application with varying degrees of efficacy. JMHO.