It's not as if a new molecule has to be put through it's paces...

It's not as if a new molecule has to be put through it's paces in the final wash up of getting our opioids approved by the FDA - the molecule has already been approved.

We are merely looking at a different delivery system. Yes we have to go back to phase I / II - but the FDA may well be attracted to the proposition of minimal side effects (side effects being their greatest dislike of these substances).

Some products with perceived greater merit have been fast tracked such as clot-busting molecules for stroke (previously approved for heart attack).

In saying this POH does have to land a deal - but if they do it with a reputable company, then there is far greater muscle for negotiating with such as the FDA.