Ann: Update - CE Marking Application, page-43

I was in OSL at some stage and missed out on its run but could see similarities with Factor therapeutics FTT , trial not up to scratch led to negative outcome of CE mark , new trial failed to produce original trial results. Not saying OSL will fail if another trial is required.

Factor Therapeutics recent AGM

"The earlier clinical work showed great healing of very hard to heal ulcers and we were all excited by the results including the physicians involved in the clinical studies. But that clinical work was not tested against a control group (standard of care) and it is this deficiency in clinical data - and this reason only - that led to the negative outcome of the EU CE Mark process. The EMA made it very clear to us that stronger clinical evidence as to efficacy was required for approval. Thus we knew absolutely in 2015 that if VF001 was ever to be approved for use we had to undertake a Phase 2 clinical trial whereby VF001 treatment was compared in a blinded and randomised way with standard of care. We communicated that information to shareholders at that time and have been consistent in that message since. "