A new Beginning..., page-2876

Just an fyi guys, from my reading, it looks like there could be another month of waiting for FDA?? ie. not 120 days, but instead 150 days.

For the FDA de novo submission review process, the FDA will go through 5 steps. I won't go through all the steps, they are available for reading here:

https://www.fda.gov/medical-devices/premarket-submissions/evaluation-automatic-class-iii-designation-de-novo

I think we can assume that we have progressed to Stage 5 (since the you would think the company would have a continuous disclosure duty to inform its shareholders if we had of received a request for additional information in Stage 4).

Therefore,
Step 5. The final step is the De Novo request decision. Under MDUFA IV, the FDA goal is to make a decision about a De Novo request in 150 review days. Review days are calculated as the number of calendar days between the date the De Novo request was received by the FDA and the date of FDA's decision, excluding the days a submission was on hold for an Additional Information request.

@Red bar your thoughts mate?

Ps. I note that this page is entitled Evaluation of Automatic Class III Designation (De Novo), but my understanding is that all de novo submissions are automatically designated Class III until it can be determined that they are either Class I, or II, or remain at Class III. Not sure if our pre-submission review comes in to play here?

Cheers.