Replies to post #773314 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

FALSE again. While the MHRA draft guideline does focus on planning future trials, it is clearly meant to support regulatory decisions, including ongoing or past trial submissions where real-world or external controls are used.

From the MHRA's own words (May 2025 draft + gov.uk consultation summary):

“The guideline provides points to consider and key principles that should be taken into account when planning a clinical trial which will include a RWD ECA and which will require regulatory approval.” “As part of our ongoing series of guidelines on using RWD to support regulatory decisions...

That last part is crucial — “to support regulatory decisions” — which obviously includes MAAs currently under review.

Im tired of correcting your ongoing made-up posts, so I wont respond anymore