EphemerisX Research · Deep research
Investigations.
Every question in the company investigations: 52 questions, each answered from the FDA's letters and the company's SEC filings. How this research works →
Aldeyra Therapeutics Reproxalap
- Did the FDA agree to the design of Aldeyra's 2024 dry eye chamber trial?Nov 2023 – Apr 2025
- Did the FDA's 2025 letter ask Aldeyra for the same study as its 2023 letter?Nov 2023 – Apr 2025
- What did the FDA's 2025 letter say about Study 030, and how did Aldeyra describe it?Apr 2025 – Sep 2026
- Did Aldeyra's second chamber trial answer the FDA's 2025 objections?May 2025 – Mar 2026
- How did a field trial left out of the June 2025 resubmission end up in the FDA's review?May 2025 – Mar 2026
- What changed between the FDA's 2025 and 2026 letters on reproxalap?Apr 2025 → Mar 2026
- Was the FDA negotiating reproxalap's label when it issued the second letter?Dec 2025 – Mar 2026
- What is Aldeyra appealing, and what had the FDA's 2026 letter recommended?Mar – Sep 2026
- How does Aldeyra's own trial table record the FDA's position on reproxalap's trials?2023 – 2026
CorMedix DefenCath (taurolidine and heparin)
- What did the FDA's first letter on DefenCath require?Feb 2021
- How did CorMedix describe the FDA's first letter?Mar 2021 – Feb 2022
- What did CorMedix say it fixed before resubmitting DefenCath in 2022?Apr 2021 – Mar 2022
- What changed between the FDA's first and second letters on DefenCath?Feb 2021 → Aug 2022
- How did CorMedix describe the FDA's second letter?Aug 2022
- How did a heparin supplier's warning letter for another product hold up DefenCath?Feb 2022 – Mar 2026
- Which manufacturer was DefenCath approved with, and what happened to the alternatives?Aug 2022 – Mar 2026
- What did the shareholder lawsuits over DefenCath's FDA letters lead to?Jul 2021 – Aug 2026
- Why did the FDA call the name Defencath unacceptable in 2022?2021 – 2026
Outlook Therapeutics ONS-5010 (bevacizumab-vikg)
- Was the FDA's August 2025 letter its first Complete Response Letter on ONS-5010?2023 – Aug 2025
- What did the FDA's August 2025 letter object to?Aug 2025
- What did Outlook say came out of its September 2025 meeting with the FDA?Sep – Nov 2025
- What changed between the FDA's August and December 2025 letters?Aug → Dec 2025
- How did evidence the FDA said did not alter its conclusion come to establish substantial evidence?Dec 2025 – Jun 2026
- What happened after the FDA's December 2025 letter?Jan – Jun 2026
- Did the FDA ask Outlook for another clinical trial, or for confirmatory evidence?2023 – 2026
- How did Outlook's description of NORSE EIGHT change?2024 – 2026
- Why do Outlook's filings give different dates for the FDA's letters?Aug 2025 – Jun 2026
Replimune RP1 (vusolimogene oderparepvec)
- What did the FDA tell Replimune before the BLA was filed?2021 – 2024
- What did the FDA's first letter object to?Jul 2025
- How did Replimune describe the first letter?Jul 2025
- What happened to the confirmatory trial Replimune said would not be viable?Jul 2025 – Aug 2026
- What was said at the September 2025 Type A meeting?Sep 2025
- What did Replimune resubmit in October 2025, and what did the FDA make of it?Oct 2025
- What did the FDA's second letter object to?Apr 2026
- Why did a different FDA team review the resubmission?Apr 2026
- How did Replimune's 8-K describe the FDA's second letter?Apr 2026
- What changed between the FDA's first and second letters?Jul 2025 → Apr 2026
- What happened inside Replimune after the second letter?Apr – Jun 2026
- How did RP1 go from a second FDA letter to accelerated approval in four months?Apr – Aug 2026
- What remains unresolved after RP1's accelerated approval?Aug 2026 –
- Was the FDA's advice to Replimune consistent?2021 – 2026
- When did injected lesions become an FDA concern?2021 – 2026
- Why do RP1's reported response rates range from 24.2% to 34%?2021 – 2026
Verrica Pharmaceuticals VP-102 (cantharidin)
- What did the FDA's first letter on VP-102 object to?Jul 2020
- How did Verrica describe the FDA's first letter?Jul – Aug 2020
- What were the “Human Factor comments” the FDA's second letter said would follow separately?Sep – Nov 2021
- Why did the FDA's second letter turn on a contract manufacturer's facility?Sep – Nov 2021
- What changed between Verrica's second and third FDA letters?Nov 2021 – May 2022
- How did VP-102 get from a third FDA letter to approval in July 2023?Jun 2022 – Jul 2023
- What is the securities class action against Verrica about?2022 – 2026
- How did Verrica's account of its three FDA letters change from 2020 to 2022?2020 – 2023
- What happened to the glass ampule the FDA flagged in 2020?2020 – 2026
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 →