This forum has been quiet for some time now, with a dabble of...

This forum has been quiet for some time now, with a dabble of understandable gripe here and there. So this is a quick regurgitation of the current situation for the any new comers.

ASX:MEB entered substantive Review process on the 24 August 2020. This should've occured "within 60 calendar days of receipt of the 510(k) submission." in this case it took almost double that time. This can be taken as delay due to the pandemic, or due to more information being requested by the FDA.

"The FDA goal to make a MDUFA Decision for a 510(k) is 90 FDA Days. FDA Days are calculated as the number of calendar days between the date the 510(k) was received and the date of a MDUFA decision, excluding the days the submission was on hold for an AI request."

"If FDA does not reach a MDUFA decision within 100 FDA days (i.e., 10 days after the MDUFA goal), FDA will issue a Missed MDUFA Communication"

100 days have passed and no Missed MDUFA Communication has been issued.

This may mean the process is on hold due to an Additional Information (AI) Request. Which Medibio has 180 days to submit. The end date for this is mid February 2021.

For those despairing, having hoped for a quick FDA approval. These are the timeline.

With the positive test results that were submitted to FDA, the recent Clinical Trial Agreement(CTA) with MedBridge in the US, and the deployment of Ilumen in Stantec. I personally believe that Medibio will receive their FDA approval. happy to hold and accumulate when chance shows.

FDA timeline reference: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process