That will hold back the biotech’s Covaxin shot by several months, and the delay put pressure on Ocugen’s share price, which fell more than 25% after the announcement.
The Philadelphia-based company said it had taken the decision to go down the biologics license application (BLA) route for Covaxin based on FDA feedback to the EUA data package it had submitted to the agency.
Ocugen added that it is now “in discussions with the FDA to understand the additional information required to support a BLA submission,” but will likely have to carry out an additional clinical trial.
