NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Mani, I was previously told that Poly-ICLC isn't yet approved for anything, it's been in Phase 2 Trials. I know an approved product can be used off label, but unless there is some legal use of Poly-ICLC, I believe the only patients that get it would be by being in a trial.

One other possibility does exist, if it's available through the right to try or compassionate use. If the company is making it available in one of these programs it may be possible to get it in spite of not being an approved product. If that's the case, I believe the company would have had to provide proprietary information to the FDA, but if they've done that, I believe they can sell it at essentially what it costs them to make it. That's the FDA, clearly the UK has a similar system which permits DCVax-L to be sold now, the same may be true for Poly-ICLC. I don't know about elsewhere.

So much has been said about Poly-ICLC, I gather that the improvement with Keytruda is substantial as well, but perhaps not quite as good as Poly-ICLC. Keytruda however is approved for other cancers and could easily be used with DCVax-L off label, and I believe insurance would accept it.

Other therapeutics, like Optivo, may also be effective, but I don't believe they've been tested with DCVax-L. I think the truth may be that many products work, or work better, when they are used with DCVax-L.

Gary