Replies to post #710948 on NorthWest Biotherapeutics Inc (NWBO)

[Nemesis18]

I would caution you that the MHRA inspection of former US Clinical Trial Sites may NOT be a positive for NWBO.
First and foremost, it shows that the Regulator will not simply just accept the trial data as presented, despite the much heralded JAMA Article.
And if not, why not ?

Finally if some serious discrepancies are found between the on-site master files and what was presented within the 1.7M page application, it's likely over for this MAA Application.

And there must obviously be some liaising between the FDA & MHRA in this matter, as a courtesy at the very least.

It all comes down to this one question..
What is the Reason the MHRA felt it necessary to have face to face meetings with US clinicians at these various trial sites.?

A: The NHRA are now clearly now checking for disparities, in what has been claimed, vs reality