Ann: Mesoblast Resubmits BLA with FDA for Ryoncil Approval, page-49

Despite the words "potency assay" not appearing in this announcement - let nobody be under the illusion that potency assays are not part - probably the most important part of CMC - Chemistry, Manufacturing and Control. Until very recently, as recent as mid March they were the part concerning Silviu (sh are ca fe video linked elsewhere).

In recently worked upon patent publications MSB agents discussed a "gold standard" in potency assays.

I am not sure that potency assays get measured in terms of gold, silver, bronze standards. I think that may have been poetic license suggesting that sometimes something less than a gold standard will be acceptable in a potency assay when the conditions being treated are of such a serious nature.

Let's just hope the potency assay is better than some toxic-lead-lining-of- the-water pipes so Rome may drink standard but it gets through anyway because Nero's and Caligula's are in charge at the FDA on the current watch. Nothing the FDA have said on their own behalf supports that.

Correlating with IL2Ralpha data from a lot of trials and sorting it arbitrarily into above and below 60% seems exactly like trawling (as DocMcStuffins puts it) to me. It would not have been had that been used only to generate a hypothesis (also as he says in similar contexts) and to then test that hypothesis in adults. But there is no skill or statistical merit in predicting the lotto numbers after the draw. And there is substantial risk in setting good science aside to pander to politics promoted by greed.

On the integrity of a few now cell medicines for many are at issue. Poor products approved may lead to poor patents being granted and a clogging of the therapeutic pipeline with the equivalent of lead-lining.