If I was the FDA I would argue that stem cells effect different ages differently as per the recent trial results.
I would also say that the FDA asked for proof from MSB and MSB's reply was that future biomarker data will be supplied, meaning they can't prove it today. Yes, I know it is a chicken and egg situation but the result is the FDA asked and MSB could not provide.
Why/how MSB didn't offer details from Japan is beyond me but from what I read, they didn't. Maybe the FDA would not of accepted it, who knows?
IMO, this is why the FDA has not been vilified. The FDA is clean in this situation.
To be successful MSB has to realise the state of play and adjust accordingly. I hope that is happening. I don't know if SI can separate himself to find a way forward?
If I was the FDA I would argue that stem cells effect different...
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