NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

If safety isn't a concern I don't think you'd here back in 30 days from the Agency but if they have other issues w the SAP/endpoints you would find out about it in the meeting/meeting minutes.

Since NWBO already had a green light on safety years before they submitted the amended SAP, as a matter of fact when they submitted the first SAP when they started out the trial, the safety is, contrary to what shorts try to claim, zero issues when the amended SAP was submitted.

So the only talking points with the FDA were the amended endpoints which the FDA had no objection to. If they had then that would be material and had to be disclosed.