In today's Stockh--d's early morning newsletter, OIL gets a...

In today's Stockh--d's early morning newsletter, OIL gets a coverage under an article "ASX health stocks are knocking on the US FDA door" The article reads:

"OIL announced earlier this month it has received feedback from the US FDA in relation to its Pre-Market Notification (510[k]} application for the InVivage product intended for oral tissue imaging.
"OIL CEO and managing director Dr Camile Farah said the FDA provided feedback that due to the first-in-class nature of the InVivage and the novelty of its intended use it could not evaluate substantial eqivalence of its device/drug combination product due to the absence of a predicate.
'As such they have deemed that the DeNovo Classification Request pathway is more suitable for our purposes' he said in the announcement.
"While this advice differs from that previously provided to the company by the FDA in Q Submission, we are encouraged by the review process and feedback offered in our recent meetings with the FDA, which have been extremely positive and productive.
"Farah said the review period has been time well spent as it strengthens our next submission.
"in addition to discussions around novelty, first-in-class, and available pathways for clearance, the FDA recommended additional studies to expedite a future DeNovo submission.
"OIL said regulatory clearance of the company's combination product mandates that both the fluorescent contrast agent drug and the device used to visualise microscopic structures are cleared for use in the intended clinical setting.
"The additional data requested by the FDA for inclusion in the company's DeNovo submission relates mostly to novelty of the contrast gent and its intended application to oral tissues.."