Thanks for the write-up Peter, just one point on the denovo...

Thanks for the write-up Peter, just one point on the denovo submission. To my mind we don't yet know FDAs position on any of the topics discussed at the recent Q-submission meeting - mainly as the company has not been forthcoming with any updates. From the recent 23 half-yearly report:

"At the end of the calendar year, the Company conducted a Q-submission meeting with the FDA and subsequently receivedfeedback on its planned fluorescein contrast agent alternative for oral use, along with qualitative studies related to theinterpretability of digital oral cavity images. The FDA has granted permission for additional clarification and feedback to befurnished in written form, to be received in Q3FY24."

"Additional clarification and feedback" from FDA could reasonably place us anywhere from being asked to generate additional data via a new study to being asked to rectify a design issue with Invivage itself. Both of which would impose many additional months of work.

It would be great if the company could clarify outstanding steps for us on the regulatory pathway for Invivage.