Replies to post #803747 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Completely agree 

[dennisdave]

Hi DD. Problem is that if GZ's "amendment" were to precede MHRA's approval, it would postpone MHRA's approval considerably and would therefore constitute a "Material Event", requiring a PR to NWBO's shareholders.
Since that has not happened, it is obvious that the amendment will be submitted after MHRA's artisan based approval.

Ok Im going to say this ONE last time (after repeating myself) because you have always been nice to me here.

Adding a CMC update to an ATMP review is not a material event. It simply is not.
CMC updates during ATMP reviews are routine, expected, and not publicly disclosed at all. Examples of ATMP programs where CMC updates were made without public announcement include:

CAR-T therapies (e.g. autologous T-cell products):
Process refinements, automation steps, facility changes, and comparability updates are frequently submitted during review or via clock-stops, without any press release or investor communication.

Gene therapies using viral vectors (AAV, lentiviral):
Changes to vector production scale, fill-finish processes, or manufacturing sites are routinely handled as CMC updates during regulatory review and are rarely disclosed unless they materially delay approval.

Autologous cell therapies produced at centralized facilities:
Updates to batch release testing, process controls, or manufacturing workflows are commonly incorporated during review as part of normal CMC maturation, with no external communication.

EMA/MHRA ATMP reviews with clock-stops:
It is standard practice for regulators to request additional CMC data during clock-stops. These are considered part of the regulatory process, not “events,” and are almost never mentioned publicly.

CMC evolution during ATMP review is normal. Silence about it is normal. Treating it as a “material event” would actually be unusual.