NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

It’s an adjuvant treatment. I didn’t say I am certain one way or the other, only that anonymous posters are not the best source, as was proven by the claim that it was fully approved. But adjuvant use is not the same as a standalone approval and it may be that the CRI is correct and we see, in fact, that the combination trial with Keytruda allows for DCVax-L and Poly-ICLC as the standard of care. Meanwhile, Keytruda, in that mix, is the only standalone drug of the 3 that is approved as a standalone drug.

Things are not always absolute, in the way we might expect. But as I said, I am not claiming it is a standalone approval. It’s an immuno-stimulant and it would make sense if, having so much data that indicates it is not a risk for safety, regulators were OK with it when it’s addition to a therapy performed as expected, as an immune stimulant and PAMP.

But I’m no ideologue. I also said I do not think it matters at the moment. DCVax-L is seeking approval as its own treatment that is part of the SOC. Their application does not require poly-iclc to be approvable.