Bibliographic record
Abstract
A Phase 3 trial wasn’t technically a condition for approval of Amylyx Pharmaceuticals’ Relyvrio, a drug for amyotrophic lateral sclerosis (ALS) that was greenlit in the US and Canada in 2022. The Food and Drug Administration and Health Canada both approved the drug based on a successful Phase 2 study. But there was pressure for a confirmatory trial, both from patient advocacy groups and from regulators. Billy Dunn, then the director of the FDA’s neuroscience office, went so far as to ask the company’s cofounders during a public meeting in 2022 if they’d be willing to pull their drug from the market, should it fail in a 664-person Phase 3 study that was already underway. The cofounders—Justin Klee and Joshua Cohen, who are also Amylyx’s co-CEOs—agreed. “If the drug’s not helping patients, then why would we want to be giving it to them?” Klee said at the time. But that’s
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.023 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.006 | 0.008 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.011 | 0.013 |
| Insufficient payload (model declined to judge) | 0.031 | 0.017 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".