According to southoz the trial in adults can be done…
….”The outcome I see most likely is that the FDA approves the potency assays and CMC issues. SI also successfully walks the FDA back from their at least one rct position. The next step (agreed with the FDA) is an adult / child propensity score matching gvhd study with the understanding that positive results may lead to approval.”…..
Now all of this needs to be negotiated with the FDA
Christmas maybe but more likely march next year we will have heard back
Money then becomes the issue
CEO Itescu needs to go, page-73
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