With all the talk of how we have failed to get approval and focus on others who have I found this comment from another ASX listed stock in their 4C a good reminder that TGA/FDA approval is not always guaranteed and can take time. There has to be an element of luck involved.
The Company is continuing to progress with regards to the US FDA Emergency Use Authorisation
application it made for the distribution and/or use of its XXX Test Kits in respect of both
nasopharyngeal swab and saliva samples, after filing its initial application in April 2021.4 XXX is not
able at this time to provide with any certainty an estimated timeline for receipt of its US FDA
Emergency Use Authorisation for the XXX Test Kits. There is also no certainty that the FDA will provide
XXX with the Emergency Use Authorisation, whether for the nasopharyngeal swab XXX Test Kits
and/or the saliva-based XXX Test Kits
I have redacted the company name lest I be blamed for cross promotion.
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