More BS from you. The historical control has since been validated by multple metheds including the FDAs preferred way which also looks at the current standard of care.
N values are high when you consider the population. 100% of treated patients are included in the Japan register.
Insurers will pay. We know this as they had listed the drug in preparidness for approval of the last BLA. The evedence is now far stronger. They were even willing to pay for off label !
Our main competition is not from other drugs, it is from other MSCs. Those that are manufactured " in house". No problem, first as our MSCs will be reimburst by insurers so no cost to the hospital network. Second and most important MSB have shown that our product is not just the standard run of the mill MSC. Way better, take a look at the survival data!
Now Doc lets move on from children, how about we look at adults. Do we have any chance of a AA for the far bigger population ?
banter and General Discussion, page-6904
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