NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

If the old FDA approval rule focused on 80% clinical vs 20% product quality/manufacturing, could it be that this new focus on manufacturing quality be the main reason for the delay in moving toward tld/approval?

GoodGuyBill,

Some of these issues were discussed at the last session of the 2021 CDDF Spring Conference (.SESSION 5: REGULATORY HOT TOPICS-Wed 10, 2021). Even my question about the use of control patients from comparable, contemporaneous trials who received standard of care therapy only (DCVax-L trial), was picked up by moderator John Smyth (Scientific Advisory Board of Northwest Biotherapeutics Inc. https://cddf.org/about-cddf/organisation/board-members/prof-john-smyth/conflict-of-interest-disclosure-prof-john-smyth/). I hope the video will be made public soon.
In summary, I don't think there is a delay in moving toward tld/approval.