RE:RE:510k updates? Timelines from FDA are defined and FDA have goals to review their 510k application.
The 60 days to review the dossier and provide questions to the sponsor. https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
At this time there are 2 options, interactive review when the questions are easy and noncomplex to answer, they don't put the submission on hold they do meeting with the company and discuss the clarification they need easy and fast process. Or they put your submission on hold for additional information request Company has 180 days to provide info. Seriously if you don't provide the answer within the first 2 months after the AI request, get rid of your clinical/development/regulatory team . but in these 2 options, they have to send you the first set of questions within 60 days. this means that base on the last PR, The 60 days is now reached and they were put on hold to respond to the Additional information request. I just think that if they do not disclose this information and that's their right,
Than why do they do a PR wto state that they filled a 510k if they don't have any intention to keep their investors informed about the current process.
HC is has totally different product classification (class IV for such device) and it is way longer than a FDA 510k review process 120 days is correct. Also HC is absolutly miserable on their delay since the Covid ERA they do not have any coordination within the different branch and teams. That's a shame.
If everything goes well for OPS. (And believe me, I fully thrust and have a great respect for (LL) and the Mgnt team). we should have news within the next 5-6 weeks, (when basic questions or clarification requested) if it goes over 6 weeks, this means that they received safety concerns questions link to potential risk and or they identified a clinical study flaws (ex. Stats or study design) that were not correctly addressed within the 510k submission.
Now it's a time to buy this stock for all the reason that you already know and you may have a good surprise in few weeks. Let's see the posivite side of it.