Ann: Change of Director's Interest Notice - Silviu Itescu, page-131

Look, I know how I said I’d stay away, but I can’t let that one go.
“… fine tuning at best”?! That is simply not true - for stem cells or any other therapy. Every regulatory agency needs to know that the cells (or drugs) you produce this week and next week, or from factory A or factory B, have the same consistency, purity and potency of action as each other. And, that they are the same as the cells (drugs) that you used to generate your clinical trial data. Otherwise how can anyone know whether the trial results are a one off from a particular batch with specific characteristics.
Interestingly, I raised this very issue with you during one of our first exchanges many years ago. It appeared to be a problem then as now.