Replies to post #415022 on NorthWest Biotherapeutics Inc (NWBO)

[trocprofit]

We wouldn't be where we are today if endpoints were a concern. "acceptance," if you will, in whatever form the FDA conveys that, was done with the revised SAP and put to bed with data lock. We are in the complicated review process of a new (external controls) evaluation process and it is taking longer, that's all.

[Maverick0408]

You’re probably right, but what I don’t understand is why they wanted to go after UK MHRA approvals first? This is what Les mentioned couple of times on that big biz show last year. If FDA had bought in at that point then why not go after FDA first or all of them together through project Orbis? Something in their strategy changed between what they were saying and planning in Aug-Sept and Oct 5 PR.