Ann: Cynata announces CEO succession and Board changes, page-37

"Your approval is worth more than a(n) FDA approval. Everyone knows that."

I don't think the FDA will approve. And I don't think they should approve on the data they've been given.

The data they've been given can't ensure that the only active ingredients (the potency factors) in the medicines received by the 25 of the 54 (that had good results in terms of survival) were TNFR1 and IL2Ralpha - because INF-gamma levels were not controlled for. INF-gamma in MSBs own slides swing around about 25% from memory and INF-gamma in implicated as a potency factor in other research that FDA reviewers like Matt Klinker are aware of because they did it.

I am not making an argument about my opinion being of particular worth I am staying the science presented seems confounded. You'd have to have some science to disagree with me in a way that I'd care. My previous comment was a bit of a warning to blokes.

And the FDA needs, by law, at least one adequate and well controlled trial to grant an approval - but - that is in their own opinion. So they may form an opinion, right or wrong, on the science and stats.

I think they'll get the call right. I think MSB will get another CRL. I think any altered potency assay will need to be verified in a new trial to show that it really is the potency factors that are the causes of the better outcomes.

If they don't do that - they can't statistically correlate cause and effect properly and the result would be bad medicines where the contents were not properly adequately appropriately (families will pay a lot for kids medicines - so it should work is they do) controlled about what is put in.