CEO Itescu needs to go, page-775

Tech investor - you ned to do a little more homework than that before dismissing the power of Mesoblast, and Prochymal's cells.

FACT - The acute SR GvHD phase three trial - the majority of patients were suffering from skin GvHD !!!!!!!!!!!!!!!!!!!!!
The company already proposed that treating skin with bloodline infused cells they submit would require a huge number of the cells due to skin being the largest organ in the body - it needs more cells.

Even in the failed Osiris trial, with the lower potency product - they already could see the product was providing benefit in gut and liver.

That benefit was confirmed in children in GVHD001, and after the MAP scale was invented and post hoc applied to the children cohort MSB had data that had achieved extremely high survival rates.

Now MSB say they have looked at their existing adult data, and they can also see a clear benefit to serious adults, considering the improvements made in the drug, and the effects those improvments had in serious children, Si has already come to the conclusion that only a small trial would be required because the data they have on hand says so. This would include data from the failed Osiris end point trials.

So the " well designed" trials may well have been well designed, but the dosing for skin GvHD was not, and so the treatment group therefore was inappropriate and end point missed as a result. The company has come a long way since then. Lets' see what the FDA think.