NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

It is great that the FDA is moving forward and expecting to see more tissue agnostic treatments and clearly DCVax-L will likely be one of the best candidates for that kind of approval, in my opinion.

However, I do not anticipate that the company will immediately apply for such approval. I think they have a trial for which I believe they can get approval, they will demonstrate and explain the mechanism of action and all that they have learned and then likely seek to validate DCVax-L ultimately as a broad agnostic treatment with likely additional trials and or real world data, if that works out to me a means to do that.

Broadly, doctors who are sophisticated will likely figure this out quickly and be suggesting it as a treatment for patients with other kinds of cancer. So I expect that they also expect that to be the case. Thankfully the real world data rules, especially the ability to expand indications and insurance coverage using them, will virtually make the drug potentially broadly available probably long before more trials and more trials will be used to reassure scientists that they are using the best combinations and treatments for their patients, not necessarily “for approvals”.