Outlook Therapeutics · Nasdaq: OTLK · ONS-5010 (bevacizumab-vikg)

ONS-5010 after the FDA's letters: the record, reconstructed.

2 FDA letters on BLA 761320, read alongside Outlook Therapeutics' SEC filings. What changed after each FDA decision, in 9 questions answered from 21 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.

Was the FDA's August 2025 letter its first Complete Response Letter on ONS-5010?2023 – AUG 2025Was the FDA's August 2025letter its first CompleteResponse Letter on ONS-5010?3 documents · 3 connectedWhat did the FDA's August 2025 letter object to?AUG 2025What did the FDA's August2025 letter object to?5 documents · 4 connectedDid the FDA ask Outlook for another clinical trial, or for confirmatory evidence?2023 – 2026Did the FDA ask Outlook foranother clinical trial, orfor confirmatory evidence?5 documents · 3 connectedWhat did Outlook say came out of its September 2025 meeting with the FDA?SEP – NOV 2025What did Outlook say came outof its September 2025 meetingwith the FDA?5 documents · 3 connectedWhat changed between the FDA's August and December 2025 letters?AUG → DEC 2025What changed between theFDA's August and December2025 letters?6 documents · 4 connectedHow did Outlook's description of NORSE EIGHT change?2024 – 2026How did Outlook's descriptionof NORSE EIGHT change?7 documents · 3 connectedWhy do Outlook's filings give different dates for the FDA's letters?AUG 2025 – JUN 2026Why do Outlook's filings givedifferent dates for the FDA'sletters?10 documents · 3 connectedWhat happened after the FDA's December 2025 letter?JAN – JUN 2026What happened after the FDA'sDecember 2025 letter?6 documents · 3 connectedHow did evidence the FDA said did not alter its conclusion come to establish substantial evidence?DEC 2025 – JUN 2026How did evidence the FDA saiddid not alter its conclusioncome to establish substantialevidence?5 documents · 4 connectedWas the FDA's August 2025 letter its first Complete Response Letter on ONS-5010?2023 – AUG 2025Was the FDA's August 2025 letterits first Complete ResponseLetter on ONS-5010?What did the FDA's August 2025 letter object to?AUG 2025What did the FDA's August 2025letter object to?Why do Outlook's filings give different dates for the FDA's letters?AUG 2025 – JUN 2026Why do Outlook's filings givedifferent dates for the FDA'sletters?Did the FDA ask Outlook for another clinical trial, or for confirmatory evidence?2023 – 2026Did the FDA ask Outlook foranother clinical trial, or forconfirmatory evidence?What did Outlook say came out of its September 2025 meeting with the FDA?SEP – NOV 2025What did Outlook say came out ofits September 2025 meeting withthe FDA?What changed between the FDA's August and December 2025 letters?AUG → DEC 2025What changed between the FDA'sAugust and December 2025 letters?How did Outlook's description of NORSE EIGHT change?2024 – 2026How did Outlook's description ofNORSE EIGHT change?What happened after the FDA's December 2025 letter?JAN – JUN 2026What happened after the FDA'sDecember 2025 letter?How did evidence the FDA said did not alter its conclusion come to establish substantial evidence?DEC 2025 – JUN 2026How did evidence the FDA said didnot alter its conclusion come toestablish substantial evidence?

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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 →