India looks dead and buried.Not looking good on approvals17 Nov 2020 09:32
Chairmans statement We have ongoing dialogue with the Indian regulators but progress has been slow. In November the FDA provided initial feedback of our EUA application, and requested additional information primarily related to new requirements and methodologies they introduced after our initial submission earlier in the year. We also provided additional data to the World Health Authority (WHO) in November. At this time we do not have visibility from the FDA, WHO or the Indian regulatory agency on approval timelines