Jul. 31 at 8:45 PM
$NGENF When Fast Track was granted a long time ago, the company was never very clear about their FDA interactions and also how/if they set up the Phase 1b/2a trial with input or agreement from the FDA staff on our primary and secondary endpoints. I would love to have been there or be able to review those meeting notes now.
Nervgen:
Please push for a Priority Review. In order to be granted Priority Review, with our current results and no other approved treatments available, the question is if SCI meets the definition of life-threatening or severely-debilitating in accordance with 21CFR312.82. This is where I would argue yes. The WHO says that SCI is associated with a risk of developing secondary conditions that can be debilitating and even life-threatening—e.g. deep vein thrombosis, urinary tract infections, muscle spasms, osteoporosis, pressure ulcers, chronic pain, and respiratory complications.