NorthWest Biotherapeutics Inc (NWBO)

[dmb2]

hyperopia, thx again, you nailed it all here.

This is when product development/launch teams appreciate the Regulatory team members. I have never seen such processing changes post clinical mfg and prior to product approval but have never experienced a length of time in development as this, over a decade. My opinion is that leachables would be a box checking, though critical, task and since Flaskworks was already being commercially marketed by Corning the overall equipment qualification tasks would be simplified.

It will be quite interesting and exciting to see if Flaskworks qualification submission is included in or submitted prior to BLA submission. If NWBO accomplishes it prior to BLA submission I will be impressed.