Replies to post #445271 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Nick119,

September 2021 (end of summer, the season mentioned for comparability studies to commence at Sawston) to September 2022 gives shareholders a 1 year time frame from which to measure potential time needed for approving the Flaskworks device as this was also the time from first patient with treatment confirmed made at Sawston to the time confirmed as GMP license granted first batch February 2021-February 2022 (see flipper44 post 445131). On a 6 month time frame for comparability studies to be completed we would be looking at the end of next month, March 2022 for approval of the Flaskworks device. Cognate/Charles River Labs seems to be only slightly behind on their hiring compared to Sawston and should be set by the end of Q2 which is the beginning of summer. We, therefore, now have a reasonable expected time line and potential approval of the device for use in Specials prior to or at the same time as approval for use in the BLA/MAA. Then again, we could always run into NWBO time again I suppose ; ). Best wishes.

[dmb2]

Nick119, thx for the additional commentary. When DI says complete the work in Q1-Q2 do you take that to mean this is the completion of the qualification work that will then enable the submission to HMRA?

If so, then it may be that they are planning to submit Flaskworks in their original BLA submission as I hope they are engaged in their BLA submission at this time. This is not a small undertaking for a small firm. The less commercial batch baseline the more work that is needed. But it sounds like it is all rolling together!

GLTA

[sukus]

Wow! Thanks Nick for sharing this very good potential timeline. Not 2 year. Not 5 year. But potentially late Q1 or Q2. :) :) :) Pedal to the metal with Tesla model S Plaid?