Replies to post #366040 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

No one can speak for the regulators but the regulators. So this is a nonsense point.

[iwasadiver]

First, there is no “Buy In” from RAs, there is mostly only criticisms and conversations saying they think the SAP might not be appropriate because of “this, this, and this reason.” This is to protect the patients who took risks being in a trial. The RAs don’t want those patient’s efforts be in vain with poorly thought out analyses that would risk failure of approval. The fact that in the UK and in the EU the RAs changed the end points on their websites shows they indeed agreed that, at worst, they did not think the SAP was out of line with approval. The FDA did or did not respond. I believe they gave more than 30 days without response, which is effectively (in FDA world) an endorsement they have no issues with it.