Aldeyra Therapeutics · Nasdaq: ALDX · Reproxalap

reproxalap after the FDA's letters: the record, reconstructed.

2 FDA letters on NDA 216442, read alongside Aldeyra Therapeutics' SEC filings. What changed after each FDA decision, in 9 questions answered from 16 source documents.

Quotes an FDA letterQuotes a company filingA line joins two questions whose answers quote the same passage. Hover a question to trace it.

Cross-investigations involving Aldeyra Therapeutics

Questions that connect Aldeyra Therapeutics's record with other companies'.

What happens after a second FDA Complete Response Letter?Divergent outcome · with CorMedix · Outlook Therapeutics · Replimune · Verrica Pharmaceuticals
What is a Class 1 or Class 2 resubmission, and how did each play out in these records?Regulatory pathway · with CorMedix · Outlook Therapeutics · Replimune
When is one trial enough? How the FDA weighed the evidence in three programsComparable evidence · with Outlook Therapeutics · Replimune

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 →

reproxalap after the FDA's letters: the record, reconstructed.

After the 2023 letter: new trials and a resubmission

First published Complete Response Letter

Second chamber trial, resubmission and extended review

Second published Complete Response Letter

Type A and Type D meetings; formal dispute resolution

Across the record

Cross-investigations involving Aldeyra Therapeutics