Replies to post #599404 on NorthWest Biotherapeutics Inc (NWBO)

[Maverick0408]

Agreed. They will shout from the rooftop when it’s accepted. It’s likely they will not PR submission but they will PR acceptance.

All this speculation and hope that approvals will drop out of thin air one day ain’t happening. Doesn’t work that way. We will find out when the application is accepted.

However, given the history of this management and the various statements in public domain, I don’t expect anything in Q2 or Q3.

[extrooper]

Why don’t you show that requirement per regulation of company traded on OTC to notify shareholders of a BLA being filed.

[improving]

NS2, If it were me vs. those fine folks trying to delay/destroy my biologic, I know exactly when I would pr MAA submission - right after I had updated my final module in accordance in with MHRA's guidance.

Regards.

The assessment of the first module will start following validation of the application. The assessment cycle will be completed within 60 days. Following each assessment cycle, a Module Assessment Summary (MAS) will be issued by Day 60. The MAS will offer the applicant opportunities to update the module which should be included in the final (marketing authorisation application) phase. The same timeline above will be applied for each modular assessment.

The rolling review is a new route for marketing authorisation applications (MAA), where an applicant for a marketing authorisation submits modules of the eCTD dossier incrementally for pre-assessment by the MHRA rather than as part of a consolidated full dossier submission.