Replies to post #302181 on NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

Thanks Longfellow.
Yeah it just defies common sense that a treatment with >20% survival at 5 years and > 40% for specific subgroups would not get approved if historical survival with SOC is near 5% at 5 years.

[exwannabe]

The FDA has occasionally accepted historical comps in trials for approval in the past nothing new here. Particularly in ultra-rare indications where executing an internally controlled trial may be impossible. or impractical.

I am not aware of the FDA every approving based on OS as a historical comp. They explicitly warn about the danger of historical OS comps in several documents.

I am not aware of the FDA ever approving on a trial that failed the defined endpoints against the randomized control arm and then using historical controls instead.

And a post-hock analysis to boot, which Dr Rago even dissed for another drug in a tweet a couple days ago.

If somebody is betting on the FDA approving based on this trials treatment group vs historical comps they should keep far away from Los Vegas.