NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Not the same ballpark at all. There are regulations that exist and are not enforced and there are regulations that are enforced.

If you do a coming soon campaign without FDA head nod, you may never be approved…ever. The drug may get approved after someone else buys it and submits, but you will never see the light of day. At least that is what I have been told is how they will treat you if you break that regulation.

My opinion of CRL remains the same, they have plenty of capacity to address US needs and more. The question was whether they still had an agreement and the tote bag must answer that as well.