$Ocugen (OCGN.US)$ OCGN announced on 27/10 that it had submi...

OCGN announced on 27/10 that it had submitted an Investigational New Drug Application (IND) to the US FDA to explore whether the effectiveness of Covaxin is applicable to the United States. This is also equivalent to OCGN starting to take the first step for the US BLA

According to the information provided by OCGN, assuming that the IND application is successfully approved, OCGN will formally conduct clinical trials in the United States, and then compare whether the results of the trials in the United States and India are the same.

According to FDA data, IND means that the drug has not been approved for sale/use in the United States.The FDA will approve the application within 30 days after receiving the IND application. If OCGN does not receive an objection from the FDA after 30 days, the trial can be conducted in the United States.

In addition, OCGN also issued a document reminding everyone that IND application is the first step in Phase 1 trials in the United States.

In conclusion, the IND application is the first step for OCGN to bring Covaxin to OCGN. The above information also reflects that OCGN has started to prepare for the BLA. Let me add one point here. Among the many BLA application conditions, the local test results in the United States must be an important part of whether the FDA approves the BLA.

In addition, everyone should be clear that this application is only an application for testing in the United States, not a formal application for the BLA. OCGN hopes to complete the test in early 2022.

Continue to wait patiently