NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

The assessment of your response to the first RFI will be completed by Day 150 (60 calendar days after the procedure restart date) and we will notify you as follows:
If your response has addressed all our questions, we will notify you as soon as possible that your application is undergoing final compliance checks.

If we identify minor outstanding issues, we will send you a second RFI letter by Day 150 (see section 2.5).
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The problem is this guidance doesn't apply to DCVax-L's MAA. It's probably for all intents and purposes what the MHRA tried to adhere to, but it's not "official".

Our MAA is in a bit of a Wild West, unregulated, open to interpretation category for MHRA because of when it was submitted.

I strongly think the simplest way to put it is that the DCVax-L MAA has been clocked off long enough that it is not yet in the 210+ days "clocked on" category, which means it isn't part of what is considered backlogged yet.

No math needed to break it down. That's just what it is, and we have to accept that. Easiest explanation is often correct-est.