NorthWest Biotherapeutics Inc (NWBO)

[Mingusahum]

Can someone clarify whether the FDA sees any data during the interim update? People seem to believe the FDA was able to share the preliminary P3 data with the PEI, but this seems to counter the process of the DMC guidelines which show that only issues of safety (during interim analyses) need to be brought to the FDAs attention.

Otherwise the DMC offers their recommendation to the sponsor (NWBO) who decides whether to take the advice, or not. NWBO may seek clarification from the FDA after receiving the recommendation, but at no point does it seem possible for the FDA to see (and share) P3 data or DMC recommendation before NWBO see it.

I'm assuming that NWBO must publicly release interim results x number of days after receiving them, though I would also appreciate if someone could clarify with sources or prior examples whether there actually is a legal obligation.