Replies to post #757 on Trevena Inc (TRVN)

[GoodGuyBill]

A few years ago the FDA rejected Oliceridine by the tiniest margin (by 1 vote) because the FDA did not have adequate safety data. Now that Trevena has the safety data, it is highly likely to be approved.

I would think the only issue here is what will the market cap be upon approval?

https://www.fiercebiotech.com/biotech/fda-rejects-trevena-s-painkiller-oliceridine

by Amirah Al Idrus | Nov 5, 2018

The FDA has declined to approve Trevena’s oliceridine, a mu-opioid receptor modulator for the treatment of moderate to severe pain. The complete response letter comes three weeks after an FDA advisory committee voted narrowly against the drug’s approval.

Oliceridine, given the brand name Olinvo, works differently than conventional opioids, the company says. It uses a different pathway to relieve pain without causing respiratory and gastrointestinal side effects that limit other pain meds.

The FDA was not convinced, saying that Trevena had not submitted adequate safety data to support its proposed dosing. Furthermore, FDA staff outlined in briefing documents released ahead of the advisory committee meeting on Oct. 10 that it has “abuse potential, overdose potential and ability to produce physical dependence that is similar to other (opioids).” The panel came down 8-7 against oliceridine, sending the company’s stock down 64%.