Replies to post #758748 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

you are an incredible gaslighter. They just began to engage consultants to prepare for other applications and you are saying they will be ready in months

Now that’s unfair as you did not parse their language enough. In NWBO-speak ‘upcoming months’ or ‘coming months’ means years, which can be expressed in terms like 12 months or 24 months or 36 months. This is why I always challenge people to be more precise with their estimate (2-3 months etc.) so that these can be tested against events as they unfold and the credibility of their future predictions can take priority predictions into account.

[Gus1212]

That was not what the post stated.

Everyone knows that DCVAX-L is first and in its current state unless we hear differently

[Steady_T]

You realize that the 10K speaks to events that happened prior to 12-31-2024.

So the consultants have had 75 days to prepare applications. Most of the work has already been done one the first application, so it is a matter of small changes to suit the individual regulatory authority.

Most of the applications are identical. The changes will likely include modifications based on the questions from the MHRA to include the answers in the application to begin with.

So yes, applications could be ready soon.

[branster]

DRHigh, Seems the consultants have been at it for 6 months according to 10-K

"Applications for Approval in Additional Countries Beyond the UK. During Q4 2024, the Company engaged specialized consultants to review the regulatory requirements for submission of an application for product approval in certain additional countries beyond the UK, review the MAA package that the Company submitted in the UK, and determine what changes or additions would be needed to adapt the MAA package for certain other applications. The Company’s work with these consultants is ongoing."

[space~farm]

I would be very surprised if they submitted to FDA in 2025.