NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

I believe Krisgo that if the MAA had been delayed because it was riddled with
major objections and therefore referred to the CHM, NWBO would have the
obligation to send us a PR because the subsequent delay could affect the SP
substantially. I may be wrong but that is what I believe.

Furthermore, all the steps that the MHRA has taken in the last few months
suggest a loosening of the approval criteria to include MAAs that are based
on comparison of results to RWE and solicitation of opinions concerning the
legitimization of MAAs that are based on RWE data (that probably include data
from similar trials) and all that suggests that the DCVax-L data (Phase 3 data, compassionate
program data and perhaps preliminary results with DCVax-L/poly ICLC), all could be
considered for approval of an MAA. In fact, it seems as if all those DCVax results are
used by the MHRA as a model/tool to broaden the criteria for approval of MAAs.
Therefore, MHRA's current tool/model is DCVax-L and it is highly unlikely that the MHRA
is going to reject the MAA, that represents the basis of the new tool/model that it hopes to
use for future approvals.