EphemerisX Research · Deep research
Questions no single company's record can answer. Each investigation connects records across companies through a specific point of evidence, and quotes every record it draws on. How this research works →
AllComparable evidenceDivergent outcomeRegulatory pathwayShared concern
Five companies, five paths. Replimune and CorMedix were approved after one more resubmission; Verrica after a third letter; Outlook's appeal after a third letter was granted and it resubmitted; Aldeyra, after a third letter, plans to appeal.
Aldeyra Therapeutics · CorMedix · Outlook Therapeutics · Replimune · Verrica PharmaceuticalsRead →
The FDA's letters to Replimune and, by Outlook's account, to Outlook said added analyses did not alter its conclusion. Replimune then went to an advisory committee; Outlook appealed to the Office of New Drugs. Both moved forward on trials already in their applications.
These records describe the classes only by review time: six months for Class 2, 60 days for Class 1. Replimune and Outlook each moved from a Class 2 review to a Class 1 resubmission; CorMedix and Aldeyra resubmissions were reviewed as Class 2.
Aldeyra Therapeutics · CorMedix · Outlook Therapeutics · ReplimuneRead →
Replimune, Outlook and Aldeyra each received FDA letters on effectiveness. One rested on a single-arm trial, one on a successful trial and a second that missed its endpoint, one on several trials with mixed results.
Aldeyra Therapeutics · Outlook Therapeutics · ReplimuneRead →
CorMedix's DefenCath and Verrica's VP-102 each received FDA letters that, by the companies' accounts, turned on a third party's facility. One was approved with the same manufacturer; the other moved its bulk solution elsewhere.
Verrica, CorMedix and Replimune each told investors that an FDA letter raised no efficacy or safety issue, or no safety issue. Set beside the letters' searchable text, each statement covers some of the letter's subjects and not others.
Prepared from public FDA letters and SEC filings: every quoted passage is matched to the original document, and every “not in” statement comes from a search of the whole document, before it is published. Questions, summaries and connecting sentences are EphemerisX’s wording. Not investment advice. How this research works → · Ask the FDA and SEC Ephemeris →
