Pinned straw:
As part of reviewing the position with NAN, I learnt more about the US FDA De Novo submission, which is the submission category NAN has done for Coris. Thought it might be helpful, not only for NAN, but for other medical device companies.
An FDA De Novo submission is an application submitted to the FDA for creating a new device product classification, of which Coris is.
The link below provides a 13 or so minute video and written explanation of what a De Novo submission is and how long it takes to get one. This is from a company which helps companies submit FDA approvals, Medical Device Academy.
The stats below was interesting in terms of number of De Novo approvals granted per calendar year and the average submission duration in calendar days. The "150 day %" refers to "FDA days" which is calendar days minus the days the submission was placed on hold - that is the FDA's KPI for funding request to Congress.
In summary, based on actual history, my expectations for Coris FDA approval is a minimum 12-18M away, closer to 18M, at the absolute fastest, so Coris earnings will realistically only kick in deep into FY26, possibly FY27 if there are delays.
Discl: Held IRL, not in SM
mikebrisy
@jcmleng the only thing I would add is that there are interim milestones in the process, which contribute to a high level of variability between one submission and the next. The milestones as I understand them are:
Acceptance Review: FDA has 15 calendar days to perform an acceptance review and determine if the De Novo request is administratively complete. If incomplete, FDA will issue a "Refuse to Accept" letter within those 15 days. The proponent can then make a resubmission and the process starts afhresh.
Filing Review: If accepted, FDA has 60 days to complete a filing review to determine if the De Novo request is sufficiently complete to permit a substantive review. FDA may issue an "Additional Information" (AI) letter requesting further information if needed.
AI Response. Applicant has 180 calendar days to respond to any AI letter with the requested additional information. No extensions beyond 180 days are granted. If no complete response, the request is considered withdrawn.
Final Decision. FDA aims to issue a final decision (grant or decline) within 150 FDA review days after receiving a complete De Novo request. Review clock is stopped when any AI letter is issued, and only restarts upon receipt of a complete response.
So, my main point is, a particular application can follow multiple paths, and the "clock" can be stopped, at points along the process.
I can't guess at the likely path for Coris, although $NAN have experience from Trophon, which presumably has similar endpoints around sterilisation.
The above also means that there is the potential for quite a bit of newsflow - good and bad - along the process. On the drug side - different but similar - holders of $BOT are living this dream/nightmare - at the moment.
Good luck with $NAN. Its price has fallen back to what I consider somewhat more reasonable value than in the past. But I find it hard to value because I am unclear what the near term trajectory for Trophon looks like, and therefore I find it hard to assess how much success for Coris is already in the SP.
Disc: Not held