could you please stop talking about what you're supposed to be? At one stage you were working at an ICU.
AND please if you're going to worry about small trials not being replicated in a larger trial, at least try to understand the difference between DRUG therapy (which can interact differently depending on individual's DNA) and stem cells which will not.
What the risk comes down to then is efficacy of those stem cells and dose. Please stop conflating terms are quite at variance because they are applying to completely different situations.
This is WHY the FDA and MSB worked on and developed entirely new protocols for stem cell approvals. Something that seems to elude you.
AND for this reason, the patient size required is LESS than with drugs because the risks are less. Stage 1 went whoosh! Because the risk to the patient is negligible. We're into stages 2/3.
This is fast tracking! Yet you don't seem to know (or is it don't want to know?)...what you have here.
thanks.
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