research reports and media, page-2221

DM - Originally the thought was to apply for Fast track early, but in one of the later discussions Dr Skerrett mentioned that the correct time may be more a fraction later, ie. closer to NDA filing point. There is prob merit of a later application as a Fast track would really only speed up the time after read out (perhaps bringing down typically what is a 6 - 12 month stage to perhaps to 3 -6 months ? - my views only).

The trial itself has to run its course, specially the durational studies and follow ups, you cant speed that up.

The only caveat to the above is something outside the box, I don't attribute much percentage to it but if the results are simply stunning at scale (statistical significance etc), there is a small chance the trial can be deemed to be open at an earlier point. (Complete speculation, chance of this happening = ?).

Other designations like Breakthrough or some sort of Priority are always possible too. Depends on a number of factors.

Certainly no harm in asking this as a question in the AGM to ascertain if what I'm saying is correct and if the thought process is any different etc.