NorthWest Biotherapeutics Inc (NWBO)

[iwasadiver]

My question is why does it matter so much to you whether the IMP Manufacturer’s Authorization is for DCVax alone or can encompass other products? What’s your issue precisely?

An IMP has to be manufactured for a clinical trial and can be used outside of the trial only under the UK “Specials” program. It’s not the same as a Manufacturer’s Authorization for a drug/treatment that’s gained Marketing Authorization. Each IMP has to be manufactured for a clinical trial and Advent’s Authorization is valid through NWBO as the sponsor of the trial and as a contract manufacturer. So their Authorization is via a contract with NWBO. Advent has no facility, NWBO does. They can’t take the authorization and move to a different site. To do that they’d have to have get another IMP Manufacturer’s Authorization for that other location. And they’d not be able to produce DCVax or attempt to gain a Manufacturer’s Authorization at a different locations without NWBO’s permission.

Now, if Advent gets a contract to develop another IMP and gain Manufacturer’s Authorization that would be an additional revenue stream for NWBO by leasing their clean rooms and office space to Advent. I’d be more apt to think if this were the case it would likely be a very good thing for NWBO and they’d never allow a competing product to be made in their own space.

So how about you just say what you’re trying to say instead of being coy about it?