Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-158

Mate you are talking rubbish, this has been addressed multiple times on this forum?

Look I'm not responding to this sort of post.

There are posters that have posted in a way that is more constructive than this and I prefer to respond to them Apologies @stockrock and @Bazsa and @ImaScientist and @whytee - it takes me quite some time sometimes to respond but your recent posts were appreciated.

Praetorian201, if you'd said some of my post was incorrect or wrong and offered evidence of that then I'd certainly have looked at what you offered.

An additional trial in children for GVHD is unethical and would not be feasible in any jursidiction, the ODAC panel said it in their transcript which is why they voted on balance 9-1 in support of approval?

I'm certain that the ODAC panel as a panel didn't say that.

The ODAC panel that voted voted on a single specific question as ten separate individuals and after voting some of them explained why they have voted yes or no but they they didn't articulate any combined panel position on the ethics or feasibility - some of them may have had opinions - Dr Joanne Kurtzberg who was at the ODAC meeting but wasn't on the panel certainly did.

The specific question the ODAC panel voted on appears in the transcript for the PM session pdf file at page 184 of 195 at line 20. It was -

"Do the available data support the efficacy of remestemcel-L in pediatric patients with steroid-refractory aGVHD?"

It is perfectly possible to vote yes to that question - I personally think that the available data did support the efficacy of remestemcel-L in pediatric patients, but support isn't the same as demonstrates or establishes or proves.

If the question had been "Do the available data (establish/demonstrate or prove) the efficacy of remestemcel-L in pediatric patients with steroid-refractory aGVHD?" Then I'd have voted no.

I do think that MSB have provided and placed some references to more data in the public domain since the CRL and the ODAC that further supports. But I'm still not sure that it establishes or demonstrates or proves - I'm still trying to work that out.