NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Mav,

We'll have to agree to disagree on 2023 being a lost year, but otherwise I think we believe in the progress being made. If we're truly in Project Orbis I'd like to know what it entails as far as what can, and can't be said.

As I remember it, members here found the MIA acceptance on a public site prior to the first official notification that it was accepted. I'd like to know if anyone knows if the MAA acceptance, or any of the other similar acceptance by any of the other regulators must be published on a site that's in the public domain.

In the case of the FDA, the PDUFA is established at the time the BLA or NDA is accepted. As I understand it, the trial site that shows all upcoming PDUFA dates is not maintained by the FDA, but rather tracks all the dates after the drugmaker announces them. If this is correct, I'm uncertain if the drugmaker has to announce the date once they're aware of it, or if Project Orbis rules actually tell them not to, or even if Project Orbis means that all four regulators agree to make a common decision that's announced simultaneously everywhere.

If someone is clear about what Project Orbis participants may, or may not do, I'm sure many of us would like to know. Likewise if anyone knows what regulators do, or don't post the acceptances of their applications, we'd like to hear what each country does. Much has been said about the UK and US, little about Germany and Canada, anything appearing anywhere could be important to us as investors.

I have no doubt that the company will announce anything that's known to come up in the public domain and be discovered by investors anyway. The question is, will they announce events that are purely left to their discretion. Of course if Project Orbis forbids any of it from being announced, we'd like to know that as well.

I believe we'll know what's happening this year, whether it includes approvals or not. It could be a good year if we learned that under Project Orbis the decision was in the hands of all four regulators, even if all approvals were not anticipated till early in 2024. I know most of us believed the UK would happen this year, but if Orbis prevents that, but has a common decision coming in the not that distant future, we should close the year substantially higher than when we began it.

Gary