Ann: Trading Halt, page-699

MSB announced that the FDA had made the "appeared reasonable"comment quite a long time before MSB announced that they'd made a IND file update - what appears reasonable as an outlined approach doesn't necessarily ensure that the supporting data in detail will actually be reasonable - the data provided when its provided - presumably at IND file update time - determines that.

MSB have spoken of a validated potency assay - but they have never said to my knowledge that the potency assay was validated to the FDA's satisfaction as opposed to it being validated to MSBs satisfaction. MSB is in my opinion (a) biased and (b) presenting itself -its trying to make its case - saying they have a validated potency assay (in their own opinion) would be necessary - they couldn't go to the FDA without such self belief - but that is in my opinion like the belief someone has to have to make a pitch, to try to persuade.

On the actual data that I've seen from MSB sources in the public domain - different lots of remestemcel-L showed some big differences in INF gamma levels. A swing of around 25 to 33 percent - measured in vitro.

Whilst generally it isn't possible to prove a negative. It is possible to show no correlation statistically by plotting a lot of examples and looking at the dot plot and seeing that their is neither a positive sloping line or a negative sloping line but rather a cloud. MSB have not shown with such a plot that INF gamma does not correlate. Yet they have shown that it swings. And INF gamma has been found by Klinker to produce an effect in research you and I have previously discussed.

I still think INF gamma is in there as a confounding variable - though I understand that you reject this. But I don't think you've shown a a basis for do so.

As I've said above - with lots of samples no correlation with INF gamma could be plotted - but no such plot has been put into the public domain by MSB.