Hi @philm23,Management have shown no tendency to date of trying...

Hi @philm23,

Management have shown no tendency to date of trying to rush through the regulatory process or cutting any corners. The very fact they have elected to delay their submission tells me they want to make the application as complete/irrefutable as possible prior to submission and make the job for the assessor straightforward. This will likely save them time or possibly even negate Steps 4 and 5 of the process. When you have as much at stake as this company does, it is not worth rushing a half-arsed job. They've clearly adopted the approach of taking their time to line up each domino perfectly and guaranteeing long-term success (or as close to it as possible), which I like for this particular situation.

I believe the reason they are waiting for Q4 to submit is the additional 100-200 SAS patients data in Q3 which will be measured under WOMAC. The bulk of the SAS results to date (everything apart of the most recent n=34) were measured under NRS 0-10 scale, which is different to the proposed phase 3 primary endpoint measurement. They are simply choosing to play it safe which is to be commended given the investor pressure they must be getting.