Trevena Inc (TRVN)

[GoodGuyBill]

Hi realfast95, No intent here to mislead. The last outcome I would want for anyone is to loose money due to misinformation on my part. Thanks for commenting on it...BUT

I honestly think my point is valid:

(1) Trvn's drug was close to being approved but for the lack of safety data.

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%.

(2) Regarding your comments about the panel, The FDA, in much more than the majority of cases, follows the outcome of it's advisory panels. In fact, the FDA follows the advisory panel 78% of the time. Of the 22% of the times the FDA deviated from the advisory panel, the FDA approved the drug 75% of the time (sometimes with some restrictions).

https://www.biospace.com/article/a-look-at-the-relationship-between-fda-advisory-committees-the-agency-and-drug-approvals/

While the advisory committees’ recommendations are not binding, the FDA typically follows those endorsements when it comes to final approval of a new drug. A recent study conducted by the Milbank Quarterly found that the FDA followed the guidelines of the scientific advisory committees 78% of the time. To come to that conclusion, researchers examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015.

Over the course of the years examined by the researchers, there were 376 voting meetings that were held by advisory committees. During that time, the researcher found evidence that showed the FDA only deviated from the recommendation of the advisory committee 22% of the time.Of those decisions that were discordant, the researchers said 75% resulted in the FDA approving a drug with more restrictive decisions following favorable committee recommendations. The other 25% resulted in the agency making less restrictive decisions after unfavorable committee recommendations.

(3) TRVN responded to FDA's complete response letter (in which the safety data was referenced) and resubmitted the NDA. The FDA accepted the NDA "as a complete response to the Agency’s 2018 letter.

https://www.trevena.com/investors/press-releases/detail/226/trevena-announces-fda-has-set-pdufa-date-of-august-7-2020#:~:text=In%20their%20acknowledgement%20letter%2C%20FDA,set%20for%20August%207%2C%202020.

FDA considers NDA resubmission a complete Class 2 response

Updated guidance on extended cash runway, funding operations into Q1 2021

CHESTERBROOK, Pa., March 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmitted New Drug Application (NDA) for IV oliceridine, the Company’s lead investigational asset for the management of moderate-to-severe acute pain.

“I am pleased that FDA considers our resubmission to be a complete response to the Agency’s 2018 letter. This represents the crucial next step to bringing oliceridine to patients,” said Carrie Bourdow, President and Chief Executive Officer of Trevena. “There remains a significant clinical need in the hospital setting for an effective and well-tolerated IV analgesic to help manage patients’ moderate-to-severe pain. We are committed to delivering oliceridine to these patients and their healthcare providers, and we look forward to supporting the Agency’s review of our application.”

In their acknowledgement letter, FDA stated that the Company’s resubmission is a complete, Class 2 response to the Agency’s action letter dated November 2, 2018. A Prescription Drug User Fee Act (PDUFA) goal date has been set for August 7, 2020.

So, I do not see this post of misleading at all...but, I know I could be misunderstanding something and may not be aware. Also, I am not an FDA/Advisory panel expert. So I welcome your comments and addition info/comments to understand more precisely why my post is misleading.

Other comments regarding your post (My response in red):
a. "The panel is other doctors in which we have no idea who they are in bed with." But even if the 8 doctors had a nefarious adgenda, TRVN almost got the drug approved...but for more safty data. Don't you think there is an increased likelihood this time around?

b. "we prefer a vast majority of the panel to vote in favor. A close vote in favor is not warm and fuzzy." Who is "We"? Are you representing or speaking on behalf of another entity? I think shareholders, above all else, wants an approval. Yes, investors would like 'vast majority' but an approval is an approval is an approval.

c. "The other big problem is that Trevena is competing against generics." I don't think that's a problem at all because oliceridine is supior wrt respatory safety and GI tolerability and need less in dosage:

https://www.fda.gov/media/121230/download (page 20)

All active treatments showed greater analgesic activity than placebo; oliceridine 3 mg and 4.5 mg had similar analgesic activity to morphine 10 mg (Figure 6; left panel). All oliceridine doses had a significantly lower impact on respiratory depression than morphine 10 mg (Figure 6; right panel).

d. So even if you win the battle (approval), they have a hard time winning the war, with payees. I am not a prophet. I can't look down the corridor of time to know this. But if I had a choice of avoiding all of opioid side effects-- renal depression and GI issues among others-- I'd would (Of course those with serious kidney issues will now have a choice!).

By the way, if it's a forgone conclusion that TRVN won't win, why is pfiser already signed up to manufacture the drug? Sounds like "we" don't want TRVN to win, lol:

https://www.trevena.com/investors/financial-information/annual-reports/content/0001429560-18-000004/trvn-2017q4ex1046.htm

The Parties shall undertake a product development project (“Project”) consisting of the development activities and applicable timelines set forth on Schedule 2.1 (“Statement of Work”). Under the Project, Pfizer shall assist Trevena to develop the Product and to obtain any required Regulatory Approval(s) in the Territory. Subject to the successful completion of the Project in accordance with the Statement of Work, and following receipt by Trevena of all necessary Regulatory Approvals, Pfizer then shall manufacture and deliver Product to Trevena for sale by Trevena as a human pharmaceutical product.

Pfizer, incidentally, is a $215B juggernaut. If TRVN/oliceridine can't win, would this agreement make sense? No?

For the record, I am not trying to pump or get into a big over-drawn argument...just putting the support for my view out there for all to see and trying to listen too to see if my info (or understanding of it) is flawed.

GLTU, sincerely

This post is misleading

the vote 8(no)/7(yes)
was a panel that helps the FDA with their decision. The panel is other doctors in which we have no idea who they are in bed with.

The FDA doesn't have to follow the vote. But we prefer a vast majority of the panel to vote in favor. A close vote in favor is not warm and fuzzy.

The other big problem is that Trevena is competing against generics.
So even if you win the battle (approval), they have a hard time winning the war, with payees.--realfast95