pmontx, 2018 it pretty close now!
You say $5 now but more later... Are there any specific upcoming milestones that will drive your target price higher? News of successful procedures coming out of the two new training centers, for example? Or specific published milestones being achieved?
Here's the list from the Short Form Prospectus, below. My personal take is that most of these should be fairly easy to achieve given the stated functionality of the device from the Nicholson surgeons. The tedium comes in the documentation for the regulatory filings, but with proper reviews before submission and working with the agencies in advance as they had been doing, risk should be relatively low. With the right QA team in place, I would not be surprised to see a few more milestones announced as completed ahead of schedule.
Quick list of Milestones:
Q3: Complete and verify system design
architecture, including performance testing in
laboratory environment and design of
surgeon simulation training modules
- Implement design changes and retest
system and subsystems
- Update Design History File and
documentation for relevant modules of
Company Quality Management
Systems (“QMS”)
- Complete initial requirements and
architecture for surgeon simulation
software and training program design,
as required in preparation for FDA
submittal
Q4: Verify system performance in pre-clinical
(live animal labs, swine), while establishing
clear regulatory pathways for US and Europe
- Complete and report on pre-clinical
live animal (swine) studies at strategic
facilities in US and Europe
- Confirm FDA and CE Mark pathways
in coordination with regulatory
authorities
Q1 '18: Complete software development, system
design and update Design History File for
regulatory filing applications
Q2 '18: Verify production system operation with
clinical experts under rigorous formal
(summative) human factors evaluation under
simulated robotic manipulation exercises, and
exercise completed surgeon simulation
software and training program
Q3 '18: Complete and document pre-clinical live
animal (swine) surgery studies that are
representative of anticipated human surgeries
for FDA submittal
Q4 '18: Prepare and submit 510(k) application to
FDA and prepare technical file for CE Mark
and submit to European Notified Body
- Publish white papers on pre-clinical
studies containing evidence of system
performance in live animal surgeries
that are representative of anticipated
human surgeries
H1 '19: Anticipated receipt of FDA 510(k) clearance
and CE Mark
