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Posted On: 12/25/2020 1:11:35 AM
Post# of 154032

Serious question about PR...
“FDA Provides Guidance for Adding an Open-Label Extension“
Does provides guidance mean that label extension is or will be granted automatically?
We’ve been talking as if it’s a done deal, and it doesn’t read that way.
TIA
“FDA Provides Guidance for Adding an Open-Label Extension“
Does provides guidance mean that label extension is or will be granted automatically?
We’ve been talking as if it’s a done deal, and it doesn’t read that way.
TIA

