Replies to post #563009 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Submitting an incomplete application does not expedite unless they are on a rolling approval basis. The FDA won’t even begin processing it until they certify that a complete application has been submitted. And then it’s not like you submit more parts of an application at your own schedule after they have accepted it as complete. Plus materials they may need to submit may be critical.

But since they were already at 750,000 pages, I’d not presume that 1 million pages is a time barrier. It’s a lot of work, but a lot of times it is more simply ensuring that all the data on those pages is consistent and correct that takes time. And no one wants them submitting a sub-standard, mistake ridden application, I would expect.

[flipper44]

Look, to me the components they worked on for the past year were likely run through regulators’ hands as a first pass, which is how tolling review is supposed to work. The final pass/filing has to be everything together — including manufacturing position. This is an orphan indication, so the MHRA (and other regulators) is/are supposed to work very closely with the company’s contractors.