NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Jeeze, you claimed they were infringing on patents. And now you fall back to statutory protection as the first assertion was BS.

So, changing to you next line (I will reply for FDA specifically, but EMA and MHRA will be the same).

1) The FDA exclusivity under Waxman Hatch (and whatever the EMA has) does not prevent somebody from running their own trials and launching an equivalent drug. It only prevents somebody from using the original approval data for themselves. So they must run their own P3 trial(s).

2) Orphan Designation (if NWBO ever gets DC-L approved) would prevent anybody from getting an ATL-DC approved in GBM by the FDA. It does not block any other indication.

SO yes, those can exist and do matter. But far from you blanket statement of "patent infringement" that would preclude somebody from commercial use of an ATL-DC.

And as we know, there are many ATL-DCs already being sold commercially in the world. Not just India (Apceden) and German clinics. But also that Spanish quasi fraud outfit that longs asserted was selling NWBO's product. Can already buy a double loaded DCVacine if you want to spend a few weeks in Cancun,

As far as infringing on trade secrets, they are not protected.

And NWBO newer patents do not protect the basic ATL-DC.

But by all means, keep on quoting Articial Idiocy. It is funny,