RE: John Rylands tweet17 Nov 2020 15:36
I think the biggest error has been in the applications and the managing of them, I'm sure lots have tests have been approved a lot quicker than GDR's...
' 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 but we believe the opportunities in these countries remain very significant. '