As you well know, the FDA demanded that the potency assays be confirmed good before any such trial would be signed off.
" Looks good "
So SI probably asked, " Can we resubmit without more data from a adult trial? We got that data from the adult companional protocol. "
FDA " Yes, great data, no need for more , just go ahead and file. After, we will look at adults. "
As you well know, the FDA demanded that the potency assays be...
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