Ann: Half Yearly Report and Accounts, page-6

Psst Thaliat and Fish , etc
It is not a quick easy process to prepare the detailed documentation required for the submission – it is not something you sit and write overnight. It requires documentation of every single study (research and clinical) that has ever been done with the drug , plus preparation of a detailed clinical trial proposal. We have had to engage FDA-experienced regulatory consultants with direct expertise in this area, and consult with US-based clinicians regarding a suitable trial design. The design of a trial that takes into consideration the ever changing COVID landscape, including exactly what types of people would be enrolled, how that would be done, where it would be done, what doctors would be involved, etc etc is an extremely challenging process. The fact that we anticipate completing this within the timeframe is actually extraordinary.