NorthWest Biotherapeutics Inc (NWBO)

[Basin Street Blues]

A question of huge importance :

Clinical Trial Websites .

EU UK , regulators manage their sites and upon acceptance of our revised SAP updated the new accepted end points accordingly

US FDA , apparently the sponsor is responsible for updating the website however the FDA do not give an official response to end point change submissions , however we seem to collectively accept that if the did not accept the changes they notify the company within 90 days .
We know this did not happen because the company would be 100% bound to PR this negative response to the application to change end points as it was the company that put the application into the public domain .

SO... when does tacit acceptance by the FDA become overt acceptance.?

Right now as we speak anyone cross referencing the slides with the FDA site will see at best confusion and at worst a failed primary end point trial outcome thus negating almost any chance of them buying in .

Does anyone please know the answer ??

Thanks in advance