GTC Biotherapeutics (fka GTCB)

[palindromy]

but it might increase the risk of non-approval to a small degree.
Dont you think it reduces risk rather than increasing it?

If the risk of approval is in the newness of the platform, I can easily see a risk-averse FDA delaying approval.
OTOH, an advisory panel given the proper data including the EU approval and followup would more likely approve with an appropriate risk management plan.