Replies to post #277322 on NorthWest Biotherapeutics Inc (NWBO)

[marzan]

lf95, I think the draft Effectiveness of Efficacy guidance document does allow comparing the results with the Historical Controls. I thought we just have to sit tight until the final document released in the Federal Register with no changes to historical control language which could happen by 28th of this month after a typical 30 days of Addressing the comments. The Comment Period closed on March 28th I believe.

[manibiotech]

Why else would they write a response ? Have they ever commented before on FDA proceedings that are not directly related to their trial ?

[Horseb4CarT]

The point regarding efficacy against particular subtypes being considered for approval is supported by the comment Dr LL made right after she stated everyone is living longer.

Paraphrasing, she said that there should be an approval path (which I took to mean at least for the subgroup(s) that appear to be benefiting like never before.