Ann: FDA clears Imugene IND for onCARlytics first-in-class study, page-148

G'day fellow IMU holders !

Does anyone with knowledge/experience in this kind of clinical trials , knows what occurs when the 100s of doctors around the globe are trying to get their patients enrolled in the trial in such numbers that far exceeds the numbers initially planned for the trial ??

I think that this could be a likely scenario if everything keeps progressing as expected ( replicating in humans similar effects to the ones observed in animals, or even just close), the we find ourselves with 1000s of patients instead of the 100s planned

Could we be qualified as orphan drug half way of the trial? If results are positive. These people would die soon (few moths or weeks) otherwise...

How this accelerated transition from clinical trial to Commercial Drug works ??

I'm electric engineer, so no knowledge in the field at all, other than as everyone here seeing cancer affecting relatives and friends.

Have a nice Sunday !