Replies to post #413812 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

You forget the whole context about the drug/biological product process in which manufacturing readiness is USUALLY THE LAST STEP (I will attach my previous post at the end as quick reference).

You missed antihamr's point,

The cGMP does not provide the certification to manufacture a specific commercial drug, It is a general certificate the the facility follows Good Manufacturing Process's.

The Pre-Aproval Inspection is what says that a cGMP certified plant is capable of manufacturing the specific comercial drug in question. That is the "last step" in the process you mention.

And that step has not started. And that is a fact (as it requires the cGMP in place).

, but I have not seen any small biotech company seeking RA approval of its drug/biological product which has put manufacturing readiness first or at least as equal as getting TLD available for the public in importance like what Linda has been doing for DCVax-L approval.

Any small biotech that elects to do there own manufacturing will get the cGMP in advance. Examples off the top of my head:
DNDN, PPHM, and CVM

For those that outsource, the cGMP will be via the CDMO. As in Advent for Specials and Cognate for the US.

The PIA does NOT happen early though, as it can not.

[antihama]

We will have to disagree on this. You’re correct if they submitted a BLA application as some/many on this board may think w this inspection being both a pre-license inspection and a pre-approval inspection but if they didn’t submit a BLA then I disagree and I don’t believe they submitted a BLA even if they know TLD. I can never see that data being kept secret once the MHRA gets their hands on it.

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? -Dan88