If it is a TGA approval that holds RNO up, it is interesting that you draw attention to ADO. If anyone wanted to write a book on the methodology to delay your approval from TGA, ADO is the case study. They harnessed labour party influenced media grabs to pressure a federal public sector body. Sadly, it was embarrassing that their second TGA submission did not establish the capability of their product through a complaint clinical trial process (same for Europe). They had not established a constructive dialogue with TGA. These learnings from ADO will litter the road to approval of many companies new to the game; maybe even RNO.
Unlike ADO, RNO has undertaken successful testing with NSW Heath Pathology and Victorian Children's. Whether the trials have been written in a accordance with the requirements of TGA is an unknown. It would not be a 5 day approval if the process is not compliant or the company doesn't have an understanding of the pathway.
BTW RNO should be joined at the hip with ADO. The synergies of their respective products are obvious. The RNO two nostril swab provides single capture for rapid test and verification by PCR, if necessary. The synergies in their inability to get the product sales necessary for the balloon to go up are also on view. Both need better logistics.
IMO RNO is currently in a better position than ADO and more likely to succeed earlier. ADO is still likely months away from TGA approval as it has started a new clinical trial. As a holder of both I hope they both succeed early.
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If it is a TGA approval that holds RNO up, it is interesting...
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