I've forgotten to add, that the Briefing Notes for ODAC is going to come out;
Probably Monday - at the latest Tuesday, as it must come out at least 2 days before the meeting...
Now those scientists amongst us can go through all the details, there's gonna be plenty of material to read.
The rest of us, well we'll just pretend that we know what we are talking about
I believe that the body of evidence is overwhelming for a +ve ODAC recommendation
There's no real need for SHs voice.
SI & Team do not do things at a whim. They are a professional outfit.
This is all careful planned and well executed - otherwise, we would have at least heard some noises during the rolling review and prior to the grant of the Priority Review - but, we didn't hear anything!
They have gone by the books and have toed FDA line for a long long time
It's time for the FDA to deliver their side to of the deal
Bring it on
The compounding news is gonna be deafening!
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