Direct quote from SI:[HA] is used here as a carrier because it...

Direct quote from SI:


[HA] is used here as a carrier because it enhances, at least in preclinical studies it enhances the migratory effect of our cells towards the site of inflammation where they have maximal effect. In the Phase 2 study, we already demonstrated the hyaluronic acid on its own was not significantly different from saline in terms of outcomes in this patient population. And so as an agent, it serves like a placebo. However, it's not approved, it's a biological agent which is unapproved and would be inappropriate to use as a control in any trial. It's just an experimental agent and it has been demonstrated in Phase 2 to have no benefit over saline. The FDA is very comfortable and has has not required HA to be a standalone control arm being because it's an experimental agent. In the Phase 3 retrial, we will be comparing one to one our cells with the hyaluronic acid carrier against the saline control. And the, if the endpoint is met, the product will be deemed the combination product where the cells will be the biologic agent and the combination of the HA carrier is used to enhance the biologic effect of the cells.