NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Anybody here disagree with Bard on this?

The 150-day assessment for MAAs by the MHRA is counted in calendar days, not working/business days. This means that all days, including weekends and bank holidays, are counted towards the 150-day timeframe.

Here's why:

The MHRA guidance on the 150-day assessment doesn't explicitly mention using working/business days.
The clock starts ticking upon validation.
The specific deadlines within the two phases (80 days for phase I and 60 days for the clock-off period) are also given in calendar days.
This aligns with the standard practice for regulatory timelines in the UK, where deadlines are typically calculated in calendar days.
However, it's important to note that while the assessment itself is counted in calendar days, the MHRA may not be actively working on the application every day. For example, they may not review documents or respond to inquiries on weekends or bank holidays.