Dr. Califf was appointed Commissioner for the new FDA whereas the old FDA had a very bad record for opioid drug approvals performance in the Commercial markets according to the Congressional hearings!
Yes, and similar to Elite, TTNP had priority review based on a plan approved by the FDA and it got rejected. Took them 2 years to resubmit and are still waiting from FDA. They have tech that avoids the oral abuse of buprenorphine since it's a subdermal implant, but for a very specific abuse population.
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