Let's talk all things public health this morning, including the fight between Novo Nordisk and hims and hers over GLP-1 drugs. Joining us right now is CNBC contributor Dr. . Scott Gotautle.He is the former commissioner of the FDA and he serves on the boards of both Aluminina, Fizer, and United Health. He's also on the CNBC cures advisory board. And Scott, thank you for coming in today.>> Thanks a lot. >> Uh, break this down for us. hims and hers big splashy announcement last week that they were going to be ...

Summary of Outlook Therapeutics FY Conference Call Company Overview - **Company**: Outlook Therapeutics (NasdaqCM:OTLK) - **Product**: Ophthalmic form of bevacizumab for the treatment of wet age-related macular degeneration (AMD) Key Points Regulatory Updates - Received a Complete Response Letter (CRL) from the FDA in late August 2025 due to the NORSE 1 trial missing its primary endpoint [2] - The NORSE 1 trial's eight-week endpoint was agreed upon under a Special Protocol Assessment (SPA) but was deemed not clinically relevant compared to the 12-week endpoint [3][5] - The NORSE 2 trial demonstrated non-inferiority and superiority against ranibizumab, providing confirmatory evidence for approval [7] - The FDA did not raise any manufacturing or chemistry, manufacturing, and controls (CMC) issues in the CRL [2][15] - A Type A meeting with the FDA was held to discuss the CRL, leading to a rapid resubmission and a Class 1 review with a PDUFA date before the end of the year [12][14] Clinical Trial Insights - NORSE 1 trial missed the eight-week endpoint but provided supportive data from the 12-week and retinal thickness measurements [4][10] - Visual acuity scores and retinal thickness changes were similar between the ophthalmic bevacizumab and ranibizumab arms, indicating a class effect [9][10] - Safety and tolerability across the NORSE program were reported as very good and consistent, addressing concerns with compounded bevacizumab [11] Market Landscape - Approximately 3 million injections of compounded anti-VEGF treatments are administered annually, with nearly 50% of patients receiving compounded bevacizumab as a first-line option [18] - Bevacizumab accounts for around 44% of all anti-VEGF injection claims, while ranibizumab has historically held a lower market share [23] - The company aims to position its FDA-approved product as the first and only approved bevacizumab for wet AMD, differentiating from compounded versions [19] Competitive Dynamics - New entrants like Eylea HD and Vabysmo are expected to increase competition, but compounded bevacizumab is likely to remain a frontline option due to affordability and access considerations [25] - Pricing strategy will be informed by experiences in Germany and the U.K., with expectations to align with biosimilar pricing [29][31] Commercial Strategy - The company plans to build a commercial infrastructure with a team of 30 to 50 personnel, focusing on market access and reimbursement management [34] - The transition from compounded forms to the approved product will depend on establishing confidence in coding, billing, and reimbursement processes [36] European Market Progress - The product was approved in the U.K. and Germany, with 77% market access achieved in Germany [39] - The company is activating hospitals and negotiating pricing, with a slower rollout in Germany due to inherent market challenges [40][42] - Future launches are planned for Austria, the Netherlands, and Scotland [44] Additional Insights - The company emphasizes the importance of a high-quality product that meets FDA standards, differentiating it from compounded alternatives [22] - The historical reliance on compounded bevacizumab raises questions about the transition to an FDA-approved product, with potential institutional risks influencing physician choices [37]

FDA Efficiency and Approval Process - FDA aims to shorten the drug approval time, currently over 10 years, by identifying and eliminating idle steps in the process [2] - FDA is considering continuous trials and reducing redundant application phases (pre-clinical, IND, phase one, phase two, FA) to accelerate drug development [3] - FDA is implementing a page limit for drug applications, similar to college applications, to enhance predictability and insight for drug makers [8] - FDA is using AI as an organizing tool in scientific reviews of drug applications, which can be up to 100,000 pages long [7][8] Transparency and Communication - FDA is releasing decision letters to improve transparency, allowing markets, companies, drug makers, and scientists to understand the review team's thinking in drug design [4] - FDA acknowledges the need for improved communication, suggesting even brief 15-minute calls with the scientific team could save companies a year of guesswork [4] - FDA aims to create more standardization and a culture of common standards to avoid reviewers acting with too much autonomy [6] Resource Management and Personnel - FDA Commissioner is assessing resource allocation to ensure scientists and inspectors have adequate resources, including 300 law enforcement officials [11][12] - FDA states that the agency will meet all targets for review decisions this year and potentially achieve a record number of approvals [14] - FDA clarifies there were no reductions in force or layoffs of scientific reviewers or inspectors [13] Leadership and Expertise - FDA emphasizes that the agency's strength does not rely on any single individual, highlighting the presence of over a thousand scientists in the relevant division [14] - FDA highlights the appointment of George Tidmarsh MD PhD, a drug developer with experience from both sides of the FDA and academic credentials from Stanford, as a top drug regulator [18]