EphemerisX Research

Cases.

An FDA decision on one product, read alongside what other companies have filed about it, up to the next decision that is still open. No predictions: what the record says, and what it does not. How this research works →

Nasdaq: INO · INO-3107

INO-3107 and the PAPZIMEOS precedent

An FDA precedent and an application under review: PAPZIMEOS and INO-3107 in recurrent respiratory papillomatosis

9 questions · 12 source documentsOpen the web →

NYSE: LLY · Jaypirca (pirtobrutinib)

Jaypirca: what changed in the evidence

Four FDA decisions on one drug: from accelerated approval on response rate to randomized trials

13 questions · 22 source documentsOpen the web →

Cross-investigations

Questions no single company's record can answer, followed across several.

What happens after a second FDA Complete Response Letter?Divergent outcome · Aldeyra Therapeutics · CorMedix · Outlook Therapeutics · Replimune · Verrica Pharmaceuticals
How did two programs move forward after repeat FDA letters without running a new trial?Comparable evidence · Outlook Therapeutics · Replimune
What is a Class 1 or Class 2 resubmission, and how did each play out in these records?Regulatory pathway · Aldeyra Therapeutics · CorMedix · Outlook Therapeutics · Replimune
When is one trial enough? How the FDA weighed the evidence in three programsComparable evidence · Aldeyra Therapeutics · Outlook Therapeutics · Replimune
What happens when an FDA letter turns on a contract manufacturer, not the drug?Shared concern · CorMedix · Verrica Pharmaceuticals
What did “no efficacy or safety issues” cover in these FDA letter announcements?Shared concern · CorMedix · Replimune · Verrica Pharmaceuticals

All cross-investigations →

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 →