Doesn't sound good
Sentiment: Strong Sell
Where is this information from the FDA?
Not necessarily. The dosing can be reviewed post approval I would think. The Adcom is focused on the delivery method (as I understand) and there isn't anything negative about that. Oh well, time will tell all.
Sentiment: Strong Buy
That screams, "No safety issue"! FDA wants to see if efficacy can be increased further with higher doses, and doesn't mean the doses tried are inadequate compared to SOC.