Replies to post #413602 on NorthWest Biotherapeutics Inc (NWBO)

[antihama]

I don't think that is a reasonable ascertain.

So is this recently happened MHRA inspection of Sawston facility is equivalent to the LAST STEP of the DCVax-L approval process, besides the obvious Advent license application?

So is it reasonable to think when MHRA issues a license to Advent, it in effect approves the commercial use of DCVax-L in UK at least?

The Sawston facility must be certified and licensed first before it can produce any drug for commercial use. Once it gets that license, it will be put on a routine inspection schedule of every 2 or 3 yrs. That is independent of a Pre-Approval Inspection (PAI) that is associated and needed for BLA approval and occurs after the BLA is submitted.

[biosectinvestor]

1) no one is “funding Advent”, this is completely false;
2) the certification is for the compassionate use program, which is already certified in London with Advent as the contract manufacturer, but that facility is too small and does not belong to NWBO and is not sufficient for later use on approval (and this larger capacity could generate early, reasonably substantial cash flow if the demand for DCVax grows after they announce TLD and prior to approval);
3) I expect whatever yet needs to happen in the ultimate approval process needs to be verified, but does not necessarily mean anything needs to be done over completely again.