I think many misunderstand the point of a true world first opportunity. Anyone care to list the experts in running CPACS trials that have successfully reached FDA approval? Yeah, didn't think so.
If you are invested in a company trailblazing, like bringing the first ever CPACS trial to the world, for example, I think it prudent to have a certain level of temperance.
I have been aware for a good while that H2 was the date for ethics submission and the company have maintained that the first patient will be dosed before the end of the year.
Call me crazy, but I'm far more concerned that they get it right when the patent clock begins. This is where time is essential, as delays will have a direct impact on value. Cooking the trial design while the patent clock is running is substantially worse than moving ethics submission from Q3 to H2 2025.
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