Jul. 3 at 8:35 PM
$CLNN I just realized that I had misinterpreted the FDA minutes. I thought the FDA asked CLENE to show that the 10% lowering of Nfl levels led to clinical benefit in the cnmau8 patients, which can be very difficult to prove if cnmau8 only helps patients to live longer in a vegetative state without improving their motor functions. Now I realize that this is not what the FDA wants to see. Instead, the FDA wants to see:
1. A clear demonstration of NfL level reduction using cnmau8. (CLENE has a ton of solid data on this already).
2. Does lowering the NfL levels (by 5%, 10%, whatever..) have any clinical benefit for patients? (This need not be cnmau8 based data. This correlation can be demonstrated from previous ALS datasets. The recent poster by CLENE in Spain just proved this correlation).
Overall, it seems that CLENE has all the data that the FDA wants to see in the NDA filing, and that this will be a slam dunk approval.
Let me know if my understanding is still wrong.
