Registered forecast
78% registered probability event by 2026-12-27 Unresolved
FDA approves fast-acting meloxicam (MR-107A-02) for moderate-to-severe acute pain on or before the disclosed PDUFA goal date of 2026-12-27
FF-047 Registered - Registered probability
- 78%
- Event by
- 2026-12-27
- Resolution window
- 2026-10-16 → 2026-12-27
- Target rung
- 5 Guideline
- 6 Regulatory
- 7 Coverage
- Baselines it has to beat
-
- Authority base rate 85%
- Calendar cycle 80%
- Analyst proxy 75%
nextconsensus.com/forecast/ff-047/ registry snapshot 2026-10-15 Share image
NextConsensus registered this probability on 2026-10-15. It is one of 26 registered FDA goal-date forecasts.
The proposition
What was claimed
The FDA takes an approval action on Viatris' New Drug Application for MR-107A-02, a fast-acting formulation of meloxicam, for the treatment of moderate-to-severe acute pain, with an approval action date on or before 2026-12-27, the PDUFA goal date disclosed in Exhibit 99.1 to Viatris' Form 8-K filed 2026-08-06.
- Authority
- US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)
- Target rungA step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung
- Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc.
- Forecast classThe group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates
- FDA action by goal date
- Scope
- Moderate-to-severe acute pain
The estimate
The number and the baselines it has to beat
The alternatives it was registered against, each with the reasoning that produced it.
ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Applications built on positive randomized controlled trials are approved at their first goal date in a large majority of cases. The calendar's own met-goal-date share for disclosed PDUFA dates does not exist yet.
A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle actions on applications like this are approvals. With no evidence input it cannot tell a strong application from a weak one.
An analyst reading the same filings on 2026-10-01 would weigh two positive phase 3 trials for a new formulation of an approved molecule against a large applicant reporting manufacturing disruptions elsewhere in its business, and would call approval by the goal date likely. Estimated by reconstructing that read, not by surveying analysts.
Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved.
The clock
Dates that constrain the record
- Evidence cutoff
- 2026-10-15
Nothing after this date informed the estimate. - Registered
- 2026-10-15
Frozen and hashed. - Resolution window
- 2026-10-16 → 2026-12-27
When the adjudicator can read the outcome. - Event by
- 2026-12-27
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
9c51088291ab311f3c636cb2e206928cd7cdccc0514f8d1f59f36c91a80149f7 · operator record jc-1792036513857-9a533f43
Around this record
- This kind of deadline
- Check it, follow it
Single-claim evaluation
Waiting on the FDA for an asset of your own?
Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page.
Resolution
The rule that settles the forecast
Meloxicam is already marketed under several applications, so this one is identified by applicant and indication, not by ingredient alone. At the cutoff openFDA listed no meloxicam NDA held by Viatris or Mylan (SRC-003, SRC-005). Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22MELOXICAM%22&limit=100 contain an NDA held by Viatris, Mylan or another Viatris subsidiary whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-12-27, and the Drugs@FDA approval letter or label for that application indicates the product for acute pain. An approval for a narrower acute-pain population or a narrower setting than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-27: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-27 resolves NO as occurred_after_deadline. 2026-12-27 is a Sunday; an approval action dated that day still counts. Read no earlier than 2027-01-10. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name meloxicam) governs, under the same applicant and indication test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands.
Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22MELOXICAM%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/
Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far.
What this record will show once it resolves
Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate.
- The finding
- As the rule above reads it: occurred on time, did not occur, or left unscored.
- The readers and their sources
- Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus.
- The number against its baselines
- 78% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them.
Reasoning
What the number rests on
The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers.
Frozen covariatesThe facts about the evidence and the authority's process that were frozen with the forecast at its cutoff
The state of the record at the cutoff
Recorded as they stood on 2026-10-15, including the 2 fields whose values were unknown then. Those are left unknown rather than filled in.
- review pathway
- unknown — not stated in the archived sources. Center CDER is the drafter's understanding, unverified.
- submission type
- New Drug Application (SRC-001); Viatris describes fast-absorbing meloxicam among its "505(b)(2) products" (SRC-002).
- evidence class
- Two pivotal randomized, double-blind, placebo- (double-dummy) and active-controlled Phase 3 trials (post-herniorrhaphy and post-bunionectomy), all primary and key secondary endpoints met per Viatris (SRC-002).
- pivotal n
- unknown — not stated in the archived sources
- endpoint type
- Acute post-surgical pain efficacy endpoints (specific primary endpoint not stated in the archived sources) (SRC-002).
- approved competitors in class
- Multiple meloxicam NDAs are approved (e.g., MOBIC, VIVLODEX, QMIIZ ODT, ANJESO, XIFYRM, QAMZOVA, ZYNRELEF KIT, SYMBRAVO per openFDA, SRC-004); none held by Viatris/Mylan.
- months since last guideline revision
- not applicable — no guideline is the subject of this proposition
- panel cycle position
- not applicable — the act is an FDA approval action
- sponsor request status
- FDA accepted the NDA for review (announced May 2026) (SRC-001); submission date not stated in the archived sources.
- odac referral
- none announced in the archived sources
- sponsor state change
- None reported for the program. Viatris reported expected product supply disruptions affecting 2H 2026 revenues (company-level; not tied to MR-107A-02 in the source) (SRC-001).
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible.
-
SRC-001Viatris Form 8-K Exhibit 99.1 (Q2 2026 results), filed 2026-08-06. States that in May the FDA accepted for review the NDA for MR-107A-02 (fast-acting meloxicam) for moderate-to-severe acute pain with a PDUFA goal date of December 27, 2026; mentions expected product supply disruptions. -
SRC-002Viatris Form 10-K for fiscal 2025, filed 2026-02-26. Describes positive topline results from two pivotal Phase 3 studies of MR-107A-02 (herniorrhaphy, bunionectomy) and lists fast-absorbing meloxicam among Viatris 505(b)(2) products. -
SRC-003openFDA drugsfda products.active_ingredients.name:"MELOXICAM" AND sponsor_name:"VIATRIS", retrieved 2026-10-01: 404 No matches found. -
SRC-004openFDA drugsfda products.active_ingredients.name:"MELOXICAM" AND application_number:NDA*, retrieved 2026-10-01 (meta last_updated 2026-09-29): nine meloxicam NDAs, none held by Viatris or Mylan. -
SRC-005openFDA drugsfda products.active_ingredients.name:"MELOXICAM" AND sponsor_name:"MYLAN", retrieved 2026-10-01: one result, ANDA077934 (generic).