Replies to post #678341 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Some primary reasons DCVax-l might be approved somewhat early are:

1. Recent commercial manufacturing certification for facility, and

Advent HTA license renewal was confirmed granted on December 20, 2023 after September 8, 2023 inspection and Advent corrections. (Note: Prior grant was in October 2021 after an August 2021 inspection).

2. Orphan designation for indication.

3. Months of mock inspection preparation.

4. A well plead complaint edited by two companies.

5. Started working with NICE long ago.

6. MHRA and NICE are in the midst of dramatically shortening review time averages. IRP program frees up national approval resources.

7. NICE gives proportionate review time dependent on safety of therapy.

8. MHRA review is smoother for drugs with low toxicity. (Near zero toxicity for DCVax-l)

[meirluc]

Hi Doc. I was not aware that NWBO had made any comments
that they expected in addition to their 150 day fast track application,
to be most likely faced with a 60 days clock off period. Also one of our
MB participants who periodically tracks the time passed from MAA submission to
the MHRA decisions has often stated that (lately?) 88% of the MHRA decisions have
been rendered within 210 days of MAA submission (or acceptance). That implies
that many applications are approved or rejected within less than 210 days and perhaps
closer to 150 days.

All those different signals are very confusing and it is very difficult to
venture a realistic guess as to when we can expect a MHRA decision.