Ann: Appendix 3Ys x 5, page-5

I'll humour your off-topic ramping for one minute. Gavint66:

"They [msb] will be the answer to medical miracles...despite what the FDA keeps blocking because it isn't a pharma drug."

You can obfuscate all you want, however the approval of Rem-L in the treatment of SR-aGvHD is reliant on approval by the FDA under one of two scenarios. These scenarios are:

1. There are exceptional results from a well-controlled clinical trial.
2. There are good results from a clinical trial and the in-vitro mechanism of action is reasonably replicated in-vivo.

The company you are in love with has issues which may be insuperable in either scenario. This is why:

1. MSB are treating children whose aGvHD is proven resistant to the standard of care. This means that if the standard of care is continued, they will die. To have a well-controlled trial, MSB would have half the cohort injected with Rem-L, with the other half receiving standard of care. Therefore, they will be sentencing half of their clinical patients to death. I think it is extremely unlikely that any clinician would recommend an otherwise eligible child to enter this trial given the inherent risks.

2. Mesoblast have consistently failed to reproduce their in-vitro results in-vivo via potency assays. They have sliced and diced data from several different trials and pre-clinical trials in a desperate attempt to show a repeatable mechanism of action. However, this is clearly not reasonable and the FDA have not been fooled by it.