NorthWest Biotherapeutics Inc (NWBO)

[austinmediainc]

I'm just going to agree to disagree. You are implying that we have full commercial production approval in which we don't. Cognate has approval to manufacture for our US Trials, and Kings and Fran have the approval to manufacture for the European trials. Fran also has approval to manufacture for the HE program (which Linda is now downplaying). We have no idea what the production capacity is. Is it 500 vaccines, or 5000? This is not full commercial production approval as you have stated. NWBO has just recently bought it's first property in the UK intended for commercial production and we have no idea how long that will take to clean, build, and get approved.

ARGS has 3rd party manufacturing in the US (as we do)for it's clinical trials and they just recently broke ground on a facility they intend to use to manufacture commercially.

So yes while NWBO IMO was very smart to start it's European trials and regulatory approval process it isn't ahead of ARGS in the USA and I'm sure they could contract out in Europe upon approval (obviously starting the process before).

In regard to the product categories, these approvals will enable DCVax-L to be produced in Germany not only for the Phase III clinical trial, but also for Hospital Exemption cases under Section 4b of the German Drug law.... Separate regulatory applications and authorizations are required, at both the Federal and local levels, for the manufacture of products for Hospital Exemption (Section 4b) versus for clinical trials.