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froggmister

01/16/26 8:59 PM

#809900 RE: Chiugray #809889

In addition to Chuigray's outstanding takedown of Hygro's argument (Chuigray's posts are not to be missed, as longtime longs here know), there's a common sense element that I believe is underplayed.

The initial submission occurred two years ago. What we are asked to believe is after all that time the company would get a response like this from the MHRA: "Northwest Bio, hey, we've been mulling this over for a couple years, hemming and hawing, and we've decided the ECAs just aren't going to work for us. Yes, when Linda Powers noted in the last shareholder's meeting that 'we are really, really gratified by how much work and how much resources the agency is devoting to our case,' it makes us realize that we have wasted an incredible amount of time and resources, which could have been spent getting other life saving and extending treatments to patients, which is unfortunate, but just can't get there. You might want to withdraw your application now."

Sound likely?
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HyGro

01/16/26 11:57 PM

#809910 RE: Chiugray #809889

You missed it - The draft guideline on real-world data external control arms states that the clinical trial protocol should include “all plans for the trial including the use of a pre-specified RWD ECA.”
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HyGro

01/17/26 12:19 AM

#809912 RE: Chiugray #809889

NWBO Near Post-Hoc Addition of the ECA Violates the Guidance of the MHRA:
#27: "Without sufficient pre-specification there could be issues related to multiplicity. For example, if
a trial is analysed without an external control, and after the analysis an external control is
added, this may inflate type I error if it is not clear which was the primary analysis. Therefore,
it must be clear what the pre-specified primary analysis for the trial is."
https://assets.publishing.service.gov.uk/media/6825bab1a4c1a40fde4e63e5/Draft_MHRA_Guideline_on_Studies_with_RWD_ECA_May2025.pdf