Clinical Hold Delays Trial. Ocugen announced that the FDA has issued a Clinical Hold for its Investigational New Drug Application for COVAXIN, its vaccine for protection from COVID-19. The IND delays the start of a bridging study designed to verify that the immune response in the US population is comparable to the Phase 3 study population. This Phase 3 data was submitted for marketing approval.Reason For The Hold Were Not Specified. Ocugen announced the IND submission on October 27, and began preparing for the clinical study. An IND becomes effective unless the FDA responds with questions or rejection within 30 days. The notification to Ocugen comes at the end of this 30-day period, but no reasons were provided. Based on previous cases, we believe the FDA could be taking extra precautions due to public health concerns and political considerations related to the COVID-19 pandemic.The Clinical Trial Had Not Started. The term used for the delay before the trial began was "Clinical Hold". An important point is that this delays the IND approval and that patients have not yet been treated. This should not be confused with a Clinical Hold during an ongoing trial, since the term is also used for trials that are halted if treatment data shows adverse events or safety concerns. Gene Therapy Trials On Track To Start In Retinal Diseases. Ocugen plans to file an IND to begin clinical trials for OCU410 in dry age-related macular degeneration (dry AMD), the first product from its gene therapy technology platform. While COVAXIN has been the product that has attracted interest in the company, we continue to see the gene therapy platform as a strong long-term technology in development by the company.Conclusion: Although the FDA action delays the start of the bridging study, we see no implications for COVAXIN. Our timeframes for the US approval were based on conservative timeframes, slow regulatory action, and small initial market share. We are not changing our estimates at this time, and continue to rate OCGN Outperform with a price target of $15. Read More >>