IMO, management made the decision to delay TGA approvals with knowledge from dialogues with different government bodies, and as per the last TGA update, we are far from missing the window. With Australia closing its borders to international travels, there little need for mass-scale screening, especially when local cases are so low as well. Yes, it is a good to have for regular testing, but the government's budget already opted for PCR testing. This is from the 17th of May:
Australian Market for Antigen Rapid Testing Australia has little to no COVID-19 community transmission and closed international borders. Travel in Australia is possible when internal borders are open, and flights regularly occur with standard maskwearing and hygiene protocols. With international borders closed, there is no requirement for largescale passenger screening.
Where screening has been required for the control of outbreaks, Australian Government organisationshave chosen traditional lab-based testing processes (PCR) to provide decision support for isolation. Recently we have been encouraged by the comments of Prime Minister Morrison regarding the use of ART for screening purposes in the future. In the near term, however, the Federal Budget announcements from last week suggest that the Government is not likely open its borders to international travel until late 2021 at the earliest, suggesting that the need for screening in Australia and the potential use of ART as a facilitation tool will not materialise until later this year at the earliest.
TGA Submission We consider the benefits gained by enhancing our QMS and gaining MDSAP certification to support a thorough submission for EuGeni in the Australian market completely outweighs the sacrifice of a 3-month market window opportunity in Australia in light of the very small comparative market opportunity currently observed.
As for MDSAP, this is what it really means, according to the FDA, in which TGA also do recognise the MDSAP as well. "The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions."
ADO Price at posting:
23.0¢ Sentiment: Buy Disclosure: Held
