NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

"In short, trying to get approved on either a subset or a secondary with the primary ITT failing is unlikely.

They need to hit PFS in the full population, probably need OS trending very well, and still need a generous review."
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I don't think so. There has been a lot more focus on subgroups lately. Further, NWBO defined subgroups before any type of efficacy look. It might makes sense for them to insist on SS within a subgroup, or projection thereof with a confirmatory, and that would be very hard to achieve unless efficacy was outstanding, but a flat rule that there would need to be SS for the broader population would seem off to me.

Biden would kick their asses if they stuck on some technicality that did not have a solid statistical basis. Matthew McConaughey and friends would help Biden.