Replies to post #454957 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Hi Jimmy. Understood what CFR is and thank you for the nice summary and discussion. I tend to think, as you suggest, the regulators are trying to be helpful, and the new rules coming into play are and have been expected to be much better frameworks for advancing this treatment, but they are coming online slowly give the previous few years. It’s just not always easy to do what people think is possible, as fast as possible.

Have a lovely morning ahead!

[dmb2]

jimmy667, agreed the FDA and other RA's are not permitted to decide which and when to adhere to their regs. Just like they use consent decree remediations as models to up the ante on compliance expectations across industry while explaining their regs are the minimum req'mts for compliance, when FDA as an example bring on new regs they typically work closely with industry and usher in changes with models. It is harder for startups to be the model because they do not have the staying power to last through the grueling timeline of such regulatory initiation but NWBO has positioned themselves to do it, as painful as it has been for many (probably most) shareholders. All my opinion.

GLTA