I was in a hurry earlier on so did not read further other than the headline. But for completeness as you seem to insist, the full statement is as below:
The meeting was positive, with a second meeting now being scheduled with the FDA in the coming weeks to finalise this review phase, thus maintaining the target timeline for De Novo clearance by 30 June 2025
So as one can see, the target timeline of 30 June 2025 remains, rather than oopss...need to do more trial. Now, I am not saying shit can't happen but until then, let's hope that the FDA approval will be achieved in a timely manner.
I stress here, NO GUARANTEE OF ANY KIND THAT THE FDA WILL KEEP TO EXPECTED TIMELINE. We are all at their mercy, like it or not. Can only hope for the best.
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