Replies to post #802884 on NorthWest Biotherapeutics Inc (NWBO)

[ilovetech]

I have Nemesis on ignore where he belongs, so I couldn't care less. There is a huge devide between the type of bureaucrat you described, and regulatory staff, as I would expect the latter to have a strong grasp of medical science. The 1.7 million pages and 27 modules filled a formality protocol, that's all. No regulator could, or would attempt to read through all that. Refer to sections for clarification more as a rule, than one would assume an overzealous review in practice.

Andrew's work has clearly shown how sophisticated medical concepts can be expressed in shorthand, which is the kind of review process, imo, reviewers follow. I think it's counterproductive to alledge that the MAA didn't have the goods to perform a proper review, but that only after something was corrected, which may have lead to more RFI's. Always defaulting to the company, and not regulatory ineptitude is beyond reason. The reviewers are a big fat mystery. But hey, that doesn't seem to prevent overinflated egos from acting, as if it must be the company.

[QL300]

I think the unofficial explanation by GZ was accurate. It was a lengthy application that required many inspections. After the MHRA cleared its backlog, the MHRA is reviewing the application in what they deem to be due course. The fact that they report the application is not affected by any backlog doesn't mean it wasn't previously affected by the backlog. I keep going back to the Advent deal as I believe that is somehow linked to approval. The 1st payment was changed to 90 days after the closing.  I don't believe NWBO makes a payment for Advent until we have approval.