Fabius- How were the studies incomplete? I think they did all the required testing. Its just that more studies were done on IV as they are going for abuse deterrent IV labeleing. I think they ran the requested tests for oral and nasal. Maybe they cut corners but I am not sure??? The oral and nasal results were not spectacular but mostly inline with ADF Oxy. I think where they fall short is when the panel is asked the question do the benefits of this approval outweigh the risks? I think the benefits are:
1. Superior IV ADF performance. 2. No food effect.
Risks:
1. Oral and Nasal ADF performance in line with ADF Oxy.
In looking at that, I don't think panel says benefits outweigh the risks as ADF Oxy is not a drug with a spectacular track record.
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