Replies to post #683709 on NorthWest Biotherapeutics Inc (NWBO)

[sukus]

Gary thought 120 day assessment is possible. “By my count we're at day T-45 based on 150 days, but the whole process could be shortened by 30 or more days, we could have approval any time in the next two weeks.”

[skitahoe]

As I understand it, the 120 day goal replaces the 150 days, it's not added to it.

All these goals are simply targets the regulators are striving to. Our FDA normally shoots for 6 months in setting their PDUFA date for anything worthy of priority review, and that certainly includes all deadly diseases, like cancer. All the regulators can delay without denying, but I believe we're in a good position to get the UK decision on time, or early.

I forget who appeared to have relationships with the UK regulators, but I believed the indication that now RFI was generated in the initial review period, so I believe that we're on track for a very rapid approval.

The only approvals I've been involved with never had the sponsor say anything about discussions with the regulator from the time they filed until they received something official from the regulator. If it wasn't an approval, they announced what was being required, in some cases it was data they could get that wouldn't cause a major delay, in others it was additional trials, and substantial delay. In every case that I believed a product should be approved, it was, but in some case it was after a multi-year delay for the new trials.

Gary