I took the time to read several previous "briefing documents" issued by FDA for previous drug and treatment licence applications, they are fairly similar in there verossity and depth of questioning for what seemed to be straight forward and positive applications.
The FDA are doing there Due Diligence.
Also this briefing has been available since Friday last week and probably would not surfaced publicly with such apocalyptic impact had it not been cleverly steered in the direction of The Fin Review and The Australian (who completely misread it thinking it was Covid Related)
"Temcell" has been successfully sold in Japan for more than three years.
This is not MSB first Rodeo I am confident they will have the answers the panel are looking for.
Please do your own research..
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