NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

"Its interesting that Hiltonol/polyicl was not mentioned at the agm. And if you Google the query Hiltonol is it FDA approved it states
The supplied Hiltonol for use in commercial production and sale of any combination production will be completed grade and meet US FDA requirements for commercial product use. BOOM!

So GENOCEA BIOSCIENCES contracted Oncovir 6 years ago to have them supply Poly-ICLC for whatever they were developing. Big deal. As it notes, it is clinical, not commercial.

Sure, if Genocea's product would be (or even is) approved, then the API they used in it (including PolyICLC) would need to be approved as a material to be used in commercial applications.

If you want to know if Hiltonol is FDA approved, try the FDA website. It says no.