Share
207 Posts.
lightbulb Created with Sketch. 101
clock Created with Sketch. 26/03/24
15:50
Share
Originally posted by JB1975:
↑
Grainger, respectfully, because of MSB's history of misunderstanding or exaggerating or putting too positive a spin on (they likely believed themselves rather than were lying) I cannot grant things are clear just because the MSB board says they are clear to them. I'd have to see the FDA communication to believe the MSB board if it said water was clear at this point. I'd think they be kidding themselves. MSB have been very clear that the potency data provided was additional analysis of the data coming from the successful phase III trial in relation to a potency assay that was used (in addition to the one submitted with the results) but not submitted. Yeah, I've spent a lot of time in the past trying to line up MSB statements into a time line and trying to work out what scientifically they could have actually done at certain time points to be actually telling the truth and for the time line still to make sense - I've considered faulty antibodies as part of tests (release tests measuring TNFR1 levels etc, reverting to old assays etc, the actually science techniques they can use are not infinite. What you can do with blood from patients - though extensive is also not infinite - you have to be able to keep it in its form at a certain time.
Expand
I can explain it and have previously. There were multiple reagents used in one of 2 potency assays used in the trial. One of these reagents had inadequate QA and as a result was too variable in quality giving poor results. SI stated to me after the AGM that he thought the original assay was superior to the one that was accepted for the Adult trial. Analyzing the original trial data using potency assays with proper QA gives acceptable new data for consideration of the successful phase III trial.
(20min delay)