NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

SO... when does tacit acceptance by the FDA become overt acceptance.?

At 30 days after submission the IND change (which is what this is) became active (assuming no formal objection by the FDA). That is what some are calling a tacit acceptance.

There is no formal blessing by the FDA of the changes being suitable for approval. That has to wait for an actual BLA submission.

The FDA will provide guidance on the question if asked. NWBO is free to release this publicly if they want to destroy the evil shorties.