Replies to post #795624 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

If NWBO chooses not to respond, then the application sits dead in the water - neither approved nor denied. Why is that so hard for you people to understand?

Because that's not how regulatory bodies work.

They have metrics, they have goals and targets, they aren't going to let this application that is blatantly scientifically invalid and dead in the water sit on their books and ruin their Christmas bonus and re-election when they could just reject it and everyone move on with their lives.

[Steady_T]

Why is that hard to understand? Mostly because it is wrong.

Innovative Medicines (new active substances, biologics, etc.):
First RFI: After the MHRA's initial assessment, you will receive a first RFI by Day 90. You must respond to all questions within six months to avoid a proposed refusal of your application. Extensions may be granted in exceptional cases.
Second RFI: If only minor issues remain after the first response, a second RFI may be issued by Day 150. You must submit your complete response within three months.
Third RFI: A third RFI may be issued to resolve any final minor issues. You must submit your complete response within three months.

Here are the relevant regulations. https://www.gov.uk/guidance/national-assessment-procedure-for-medicines#:~:text=If%20you%20do%20not%20submit,150%20(see%20section%202.5).

[meirluc]

Why is it so hard for you to understand that if the MHRA had determined that
the P3 trial had failed, they would have known that a very long time ago and would
not have waited long thereafter to reject the MAA. Since that has not happened,
we can rest assure that the MHRA had judged the trial to be a success.