OTLK - Outlook Therapeutics: Worth A Good Strong Look After CRL
2024-06-13 17:22:01 ET
Summary
- Outlook Therapeutics received a Complete Response Letter from the FDA in August 2023, causing a 74% drop in share price.
- Following a Type A meeting with the FDA in November 2023, Outlook agreed to conduct an additional clinical trial for ONS-5010.
- Its recent Special Protocol Assessment with the FDA sets it up for filing a BLA if the trial is successful in Q4, 2024.
- ONS-5010 has blockbuster potential.
This is my second Outlook Therapeutics ( OTLK ) article after 04/2023's "Outlook Therapeutics: August PDUFA For Wet AMD Blockbuster". In that article, I pegged Outlook as a high risk high reward bet on a successful PDUFA. I took the bullish bet, rating Outlook a Buy....
Outlook Therapeutics: Worth A Good Strong Look After CRL