Sorry, perhaps a newsletter was the wrong term to use. You can sign up for email alerts which will give you an auto email for any events and/or presentations that Sage announces. There’s things like quarterly shareholder calls and other conferences where they give presentations - sometimes they give insight into their drug candidates. They will obviously announce data read outs of their trials too.
They’re providing an oral drug (sage-217) that is meant for once a day dosing. Whether you have to take the drug chronically or periodically is still to be clarified from your phase 3 study.
As far as dates, their final, pivotal trial is expected to be completed by November 2019. If the data read out is positive from that, Sage applies for a New Drug Application and then the FDA reviews that Application. If the FDA is satisfied with the trial, they allow for the drug to be prescribed to the general public.
So when would this drug actually be released to the general public? Well, Sage also has an IV (injection) drug very similar to sage-217 called Zulresso (which was formally known as Brexanolone or Sage-547). Zulresso is on the verge of acceptance from the FDA (the exact date is actually sometime in December of this year). All-in, it took Sage twelve months to go from Zulresso’s phase 3 completion to FDA’s acceptance. So using that estimate, we could estimate that Sage-217 would finish its phase 3 in November 2019 and then get clearance from the FDA around November 2020. I’d say we’re just over 2 years away from this.
Once it becomes available, it would be akin to being prescribed an anti-depressant. You go to the doctor, say you’re suffering from major depressive disorder, hint that you heard about sage-217 (which will renamed at some point), and you go pick up your prescription. In regards to cost, no one really has an idea. However, if you think of new anti-depressants when they came out like Zymbalta - maybe a couple hundred bucks a month if you don’t have coverage from work? I would highly doubt this would be cost prohibitive to the average person.
Correct, there has historically been no way to treat the deficiency directly. People will have a million theories of what went wrong and why we are in this mess but here’s my opinion: I agree that Melcangi’s study back in 2017 showing a ~300% reduction in Allo is very important. Melcangi’s most recent study showed lack of neurogenesis and increase in inflammation in the hippocampus - both as a result of the lack of Allo. Melcangi’s most recent study even showed that we have emotional impairment and long-term memory impairment likely from the changes from inflammation and lack of neurogenesis. Therefore, the cause of whatever you want to call it being from changes in the gut microbe, down regulation of 5ar, etc. If we can get some solid relief from now having Allo in our system, that would a huge increase in the qualify of life we live. I’m carefully optimistic.