Has the company made any mention anywhere about pursuing the TGA "priority review" pathway? All the announcements suggest going down the "provisional approval pathway". This article suggests that they are 2 distinctly different pathways. The time taken for "priority reviews" ranged from 80 to 147 working days with an average of 113 working days, based on the 15 approvals up till July 2019. This would be much quicker than up to 255 working days for provisional approval. I thought their November 2019 meeting with the TGA to establish "unmet need" was for the purposes of qualifying for priority review, however, I can't seem to find the company using those words anywhere?
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6698240/
research reports and media, page-763
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