NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

For the FDA, they inform the sponsor of concerns as they arise. That allows the sponsor to fix minor issues on the fly. If a NDA/BLA is rejected (CRL'd) the sponsor will have heard of the reason in advance.

But the FDA may raise concerns that are borderline, in which case the sponsor may not know until the final action. In that case the sponsor gets the notice (approval letter or CRL) and it is up to them when it is made public. I do not remember the Martha Stuart story well enough to know if they sold after the CRL or not.

The EMA is a lot more formal. I think the sponsor is updated at specific times, such as the cock stop and CHMP meetings. But really do not follow them close enough to be certain of details.

I have no clue about the MHRA. Would suspect somewhere between the other 2.