RE:RE:RE:RE:RE:RE:Accelerated Approval, surrogate endpoints, registration
For those that are suggesting that the company has removed all references to phase 3 it all depends upon the terminology being used.
From the August 2023 investor presentation the graphs showing the trial phases and how far along they used to be always said phase 1 , phase2 and phase 3 and yes that has changed in the latest from phase 3 to license enabling study.....BUT also in the same presentation they refer to license enabling study more than once throughout the presentation so that terminology was used last year.
From the presentation August 2023 and this was in reference to the panc trial when we had been selected for the precison promise trial....
Reduces the cost of a licensure-enabling study by approximately 50% compared to traditional phase 3 trials
So for those that are worried , it is only a change of wording but references the same type of trial that is used for fda approval.