NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I think if someone can separate all the accelerated pathway products we'll find that the UK is largely out on time, or early. Our FDA is acting by or before the PDUFA date most of the time as well. It's my belief that most early decisions are approvals, when they go right down to the wire it can go either way, and often is a CRL.

March is the very earliest I believe the UK could act, but in April or May it could happen any day. I'm not suggesting early March is possible, only very late in the month at the earliest. While I certainly feel good about an approval, that doesn't mean the UK or anyone else may not want to see additional confirmatory trials. I would hope that all future trials can add the drug combinations which the clinicians have shown to achieve the greatest results in early stage trials.

The sooner the EDEN unit is ready for commercial production the sooner we'll apply to the other regulators IMHO.

Gary