Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-145

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.

Since ODAC they haven't really publicly disclosed detail - but detail is in their patent applications and other papers. And science isn't magic to those with sufficient skill in the art.

If you can explain the organge bit in the sentence of yours that I've highlighted I'm all ears - but I know the history of MSBs matrix approach to potency assays and I think I know the sort of things they could do to supplement a matrix approach and I don't see any evidence that MSB has done those things in the timeline.