The FDA understands it needs to tackle the prescription opioid epidemic. It told Elite the fatty meal "issue" was a label issue previously and now it has said it is a "safety" issue. Typical big government BS it states one thing and then behind closed doors it does another.
Eugene Pfeifer will come away with a path forward for Elite. Some say Elite wasn't blind sided by this.....as if hiring Eugene Pfeifer post NDA submission doesn't say otherwise.
And one has to keep in mind the FDA previously telling Elite they didn't have to perform a phase 3 trial and then "changing" their mind thereafter.
Nasrat came from the big leagues. He is the consumate professional. He'll figure out what is necessary to move SequestOx to market IMO.
how do we know this is the best product? Is there data in the scientific literature? i ask because I have not seem any such data, therefore it is pure speculation that this is the best product