"it looks like we have an approval but with strings attached"
@Pixie, I reckon you've nailed it.
It's the only explanation that makes sense to me. SI & Co need the next few days to work through and respond to the "strings attached".
If it was just straight approved, no need for a TH.
I can't believe that it was outright rejected, and cite the following:
Rem-L wins the Fierce Biotech Innovation Award.
Rem-L wins the ODAC approval by 9 to 1
The FDA has already granted an EAP for use of Rem-L (Ryoncil) for children aged from 2 months to 17 years.
How could they knock it back?
"it looks like we have an approval but with strings...
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