NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

A desperate biotech that knew they wasn't going to get FDA review, let alone approval. So they frantically spun the data and tried to find a market they had a chance, or who at least would let them file for approval. FDA wouldn't.

NWBO knew they were toast at Dr. Liau's Interim analysis when there was no set of PFS results that showed they would meet their primary endpoint. So they had to spin the protocol, endpoints, comparator, add the R/R that wasn't even part of the original protocol. Very clever manipulation, but FDA wouldn't buy it. But EU and UK talk to the FDA too.

If FDA rejects or refuses to file a development-stage drug, that fact and the detailed reasons generally remain non-public and are not automatically transmitted to foreign regulators, even where information-sharing arrangements exist.
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Targeted exchanges can occur (for example, around data-integrity problems) under Confidentiality Agreements, but they are discretionary, structured, and limited to what FDA is legally permitted to disclose and believes is necessary for regulatory cooperation or public-health protection.