FDA Has Denied The Pediatric Emergency Use Application (EUA). Ocugen has announced that the FDA has declined its EUA for pediatric use in the ages 2 through 18 group. Although its approval would have been positive sign for full product BLA approval, we do not believe its denial will have any impact on the BLA for adult use.BLA Application for Adult Use Is Unaffected. Ocugen did not give details about the reasons for the denial, only saying that it will "continue working with the FDA to evaluate the the regulatory pathway for COVAXIN." We believe the FDA is highly unlikely to approve additional COVID-19 products under Emergency Use guidelines, and that the COVAXIN pediatric indication submission will be reviewed through the regular BLA approval pathway.This Does Not Change Our Opinion About COVAXIN. We continue to believe that COVAXIN will be granted approval by both the FDA and Health Canada. In our view, an important difference is that COVAXIN is produced using long-established methods for antiviral vaccine production. These methods have been used to produce many different vaccines with long histories of safe use. This gives the public an additional vaccine option which could address safety hesitations.We Continue To See Advantages For COVAXIN Compared To Other Vaccines. In addition to its production methods and their established safety, COVAXIN produces a broad polyclonal response and has efficacy data against numerous variants. It does not require frozen storage, and has a 2-year shelf life at refrigerated temperatures. We believe this will make it practical and highly competitive for routine medical practices.Conclusion. We believe the that COVID-19 is no longer the public health crisis it was in 2020-21, and that the FDA is unlikely to grant future Emergency Use Approvals. We also believe the scientific and political environment around COVID-19 explains the delay for the bioequivalence study IND. We reiterate our Outperform rating and price target of $15 per share. Read More >>