RE: Maybe August23 Jul 2020 09:57
They just seem slow, why did they take so long to apply for approval in their target markets? Why didn't they say when they applied for US approval?
The Company's main commercial efforts are focussed on India, Africa and the United States:
- Indian approval was applied for in mid-June and the process is ongoing. The Company remains very confident that rapid commercial roll out could be achieved in India through both existing distribution partners and DIVOC Health, a new COVID focussed partner in India.
- The Company has signed a number of distributors across Africa and is in the process of registering the product locally. The CoV-2 Test was submitted for WHO approval in early June, although this is not a primary focus for market entry as many African countries have their own approval processes.
- In the United States, Emergency Use Authorisation (EUA) has been applied for and remains under consideration by the FDA. The Company has been in discussion with several interested partners to access the US market, but all discussions have been subject to receipt of EUA approval.