Replies to post #741503 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Over the years, a number of posts have made reference to Project Orbis. It's the first time I see a concrete use of Project Orbis. And it's for a cancer treatment. As Senti would say, I'm wondering if that's a rabbit L.P. is going to pull out of the MHRA hat.

Orbis is a scheme where other RAs can participate in (or just be provided details of) the FDA review. It does not work in the other direction.

Things like Orbs and IRP (and for the UK, the old "reliance" process) are programs that are designed to make it easier for the smaller RAs that simply do not have the resources the FDA, EMA or Japan's PMA.

They are also reasons why virtually every company goes to the big 3 first. They are faster, and once approved by them the smaller RAs follow. Not the reverse.
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