Replies to post #496892 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

we have not seen the basis to this 30 days claim so I believe it is premature to get expectations up at this point. imo

[Red_Right_Hand]

We found out on July 6th that the manufacturing application was submitted, but the PR contained a quote from Advent stating "Our Team has put in an extraordinary effort to meet our self-imposed, end of Q2 deadline to submit the MIA application." So that means the MIA was submitted by 6/30 (and was not PR'd until at least a week later).

It takes 90 days, excluding weekends and public UK holidays, to rule on the MIA so they should have an answer by 11/9/2022.

If they submit the MAA by July 30th (30 days after the MIA), then they should have an answer no later than 2/25/23 under the 150-day assessment process (which can take 210 days), or by 12/7/22 if they are submitting the final phase of an existing rolling application (which can take 130 days). Both of these times are maximums and can be shorter.