News Focus
News Focus
icon url

baltimorebullet

05/26/19 11:33 AM

#194375 RE: XenaLives #194363

If A2-73 were approved for sleep benefit only would that mean that if approved later for cognitive, motor skills, seizure, ect. that might mean a longer period of exclusivity?

Poorly worded perhaps, but I'm sure you get my point.

BB
icon url

anders2211

05/26/19 1:28 PM

#194392 RE: XenaLives #194363

With a high safety profile improved sleep will be sufficient reason for approval based on this sort of analysis.



Yes about the sleep improvement.
On what basis would A273 be permitted if only as an improvement of sleep?
Would that be for people who take sleeping pils from time to time just because they have trouble sleeping and have no indications of CNS problems?
Or would that be for people who do have CNS problems and trouble sleeping and they could benefit from A273? In any case there is need of proof
And that proof is in the data of the read out. And if that read out is indicating it improves the problems of CNS then as a wonderful side effect sleep problems diminish. In other words... I do not see A 273 improve sleep for people with CNS problems if it does not help the underlying CNS problems. So then we are back where we were and that is to wait for the complete read out of the trials...