TrivarX Requests Pre-Submission Meeting with US FDA
Today, our AI mental health Investment TrivarX (ASX: TRI) announced that it has requested a pre-submission meeting with the US FDA to finalise the protocol for a pivotal clinical trial of its AI-driven algorithm MEB-001.
Positive results from this trial would support TRI's application for FDA approval of MEB-001 via the De Novo pathway for novel medical devices.
TRI recently released successful Phase 2 trial results for MEB-001 in screening for major depressive episodes using patient sleep data:
TRI’s Phase 2 Clinical Trial Results are in…
Today’s announcement said that following the Phase 2 trial results, “several prominent US sleep centers and research organisations have expressed interest in collaborating on the pivotal trial.”
The strong interest from potential commercial partners is an encouraging sign and could bode well for commercialisation, should FDA approval be secured.
Achieving positive pivotal trial results and subsequent FDA approval would be major catalysts that could allow TRI to commercialise MEB-001 through partnerships or licensing deals.
How does this impact our TRI Investment Memo?
Today’s news relates to a key reason we Invested in TRI:
Path to FDA approval
TRI has engaged with the FDA and the De Novo pathway was defined by the regulator, a type of FDA approval which is generally longer and more rigorous but reserved for genuinely new medical devices, which we think TRI’s algorithm is.
Source: 2 May 2024 TRI Investment Memo
So we’re glad the company is now engaging with regulators.
This further’s Objective #2 from our TRI Investment Memo:
Objective #2: Regulatory approval - FDA De Novo application
TRI will be engaging with the US health regulator (FDA) to bring its product to market. This involves an De Novo application - which would classify its product as “low-risk” and therefore help speed up the approvals process and get TRI’s product to market quicker.
Source: 2 May 2024 TRI Investment Memo
What’s next for TRI?
We are primarily focussed on Objective #4 from our TRI Investment Memo now:
Objective #4: Complete Pivotal Study
Milestones
🔲Complete Pivotal Study Design
🔲Appoint CRO for Pivotal Study
🔲IRB Approval for Pivotal Study
🔲Commence Pivotal Trial
🔲Interim Results
🔲Complete Recruitment
🔲Final Results
But we’d also like to see progress on appointing an MD/CEO as well:
🔄CEO appointed
