@BiotechAutist From a stats POV, the original 8-mo control OS assumption was way off. Napkin math gets pooled OS to 20-24 mo based on the enrollment timeline. Tough to see how the study is sufficiently powered now when the SAP requires a HR of 0.636 to hit stat sig.
@BiotechAutist After a 2nd CRL I usually unfollow a ticker. I never realized they ran up again and I’m happy to short it again, thanks for the heads up. Side question, any thoughts on $SLS? Biology seems destined to fail but not my wheelhouse.
@KVN_03 Downside is the CPAP 100% cures sleep apnea and oxygen levels return to near 100%. The pill is a 50% increase so 80% -> 90% for example. Nothing will ever be as effective as the CPAP but it doesn’t work unless you use it
@KVN_03 They pills will get approved just a matter of time. It’s a combo of an old overactive bladder med and a semi recent ADHD med. One makes the throat muscle stronger and the other keeps the throat from it falling asleep basically. Very safe, limited side effects
@KVN_03 Reach out to ApniMed at “[email protected]” they have the first oral sleep apnea medication which should be getting fda approval next year. I’m sure they’d love you as a patient advocate
@drjohnm@VPrasadMDMPH It was a 40,817 person trial against standard of care you idiot. It doesn’t get more rigorous than that and the FDA previously stated that it would be enough for approval