For what its worth , here are my 2 cents.
Back in 2011 it was highlighted that to approach FDA or other regulatory bodies and get the drug on the market there are 2 pathways.
One of them was - "any validated endpoint and a functional measure"
It would seem that lower deaths could be a functional measure given that deaths are more likely due to post injury seizures. They measure the bio markers within 5 days and then a follow up over successive periods. They have highlighted this multiple times in the announcements warranting that it is more statistically significant then its peer groups. This could also become a validated endpoint once it is opened to be inspected.
Most drug companies usually take the second path to the regulatory approval proving post injury seizures as a single endpoint. However, Neuren seems to be keen in appearing thorough in presenting what it believes will have no post approval hiccups like the case of ACR.
NEU Price at posting:
9.3¢ Sentiment: Hold Disclosure: Held
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