The U.S FDA has told Ocugen Inc (NASDAQ: OCGN) that it has put its Phase II/III study of COVAXIN on hold. The FDA decided after the company chose to implement a pause in patient dosing temporarily.
The WHO put out a statement on Bharat Biotech International
This pause came after Ocugen started evaluating World Health Organization (WHO) statements after the organisation inspected a manufacturing facility owned by Bharat Biotech International Limited. Ocugen has stated that it will cooperate with the FDA and answer its questions.
Ocugen has recently entered the COVID-19 space and is trying to develop a vaccine. However, its decision to stop dosing has put a hold on the project. The company wanted to test COVAXIN, which it licensed from Bharat.
Because the FDA has put the vaccine on hold, it can’t continue with its bridging study. The study was to evaluate how patients from Bharat, which is in India, would respond to the vaccine in comparison to U.S patients where Ocugen is.
The company has stated that the FDA has not given it a reason for its decision or a way forward to correct any drug errors or trial errors. Ocugen believes that the FDA might be cautious as there are many concerns with public health.
The hold will not affect the trial
Despite the setback to the study, Ocugen has assured investors that the FDA’s decisions will not impact COVAXIN. The reason is that the company had taken matters like an initial small market share and slow regulatory activities into consideration when it developed its timeframe.
Furthermore, the trial was still at the beginning stages; thus, the hold hasn’t significantly impacted the company. Meanwhile, the company intends to file another IND for a therapy that could potentially treat macular degeneration.
Ocugen, a biotechnology company, focuses on marketing, developing and discovering vaccines, biologicals, and gene therapies to improve the lives of people worldwide. The company tries to make ground-breaking innovations to improve its patients’ lives.
Ocugen has a gene therapy platform that tests various illnesses using one drug. The company is also developing therapies for patients with diseases with high unmet needs.
