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The company is "...doing a lot of preclinical work to complete a package for an IND filing for sometime in the fall, for the full-blown phase two clinical trials for BOL-148.”  They have acquired a patent to make BOL without having to use LSD to make it.  That's a big deal.




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Whoa - wouldn't that be incredible if someone was actually able to get BOL-148 fully approved, manufactured and available for prescription?

For that matter over the counter availability would be fine with me :D.

To see this non-hallucinogenic version of LSD, reputedly much more effective for CH, finally become available could be such a game changer, and such a longer than lonnnnnng time coming after it it's promise has been known for so many years, with the maddening (and then some) history of false starts. :o

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I agree with @Chris Moore. Surely there's something the CH community can do to help things like this on their way?

I just find it completely staggering that, despite the obvious potential of BOL-148, that here we are over 10 years after a successful study, this option remains elusive as a treatment.

I find it so damn demoralising that options exist to potentially change lives and yet those things don't reach patients at all, or at least not in legal ways. It's kind of abhorrent, for example, that CH sufferers who benefit from psychedelics have to break the law - a face considerable jail time - in order to do so. It just seems inhumane that governments and the medical community aren't able to make pragmatic decisions in the interests of reducing suffering.

There just seems to be a whole lot of hypocrisy where it comes to pharmaceuticals. So many legal prescription drugs that are capable of far greater harm than currently illegal therapeutics. It just makes me feel depressed that we've not been able to move forward as a human race to make more pragmatic decisions.

I just really hope we're on the verge of change this time around. It's just appalling that people have to suffer great pain when there really might be a solution already out there. It's just wrong.

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Agreed -- it's stunningly wrong.  (I should mention that the BOL trial was funded by ClusterBusters.)

Many of us here (or several of us, at least) have observed or participated in many experiences of trying to make BOL available over the past ten-plus years.  A company, Entheogen, was founded in part for that purpose.  But Entheogen couldn't raise enough money to do the necessary clinical trials toward FDA approval. Clinical trials are very expensive, and among other things potential investors didn't see the potential market as big enough to justify the investment -- not to mention that at least at that time, there was a real concern that an LSD-based substance could not get approved no matter what the trials said. (The trial funded by CB didn't meet any of the criteria for rigorous clinical testing.)  There were patents to be dealt with, not just the patent for BOL itself but also a patent that was taken out for using BOL to treat CH.  That patent created a pretty ugly rift between two doctors who were very big supporters of CB and pioneers and the use of psychedelics to treat CH.  (Money changes everything, as they say.)  As the article notes, a big deal now is the ability to make BOL without starting with LSD. So, prayerfully, things are better now in many ways. One of those ways, which is a double-edged sword, is the potential for BOL to serve a much bigger market than the CH community. If it has potential as a treatment for depression, for example, there will be much more interest in making the investment--but the clinical trials will probably focus on that, and possibly mean that BOL would be available, but its use for CH would be "off-label" in the sense that it wasn't demonstrated by clinical trials.

If you're a drug manufacturer, you have an additional issue related to CH. If doctors don't diagnose CH correctly, they won't know that their patient will benefit from BOL. And even if they do diagnose CH correctly, we have seen that way too many doctors don't even prescribe oxygen, or don't correctly prescribe practically anything. In part, they don't prescribe O2 because they have no familiarity with high-flow O2 with their patients, so they are reluctant/afraid to prescribe it.  It might be tough to get them to prescribe something LSD-based.  (And I remember reading somewhere that most doctors believe that they are very effective at prescribing for CH. Probably because their patients don't come back, or don't know any better.) So you have a massive education campaign to do to (1) get CH diagnosed properly, and then (2) get BOL prescribed. The cost of that is part of the cost-benefit analysis that goes into pharma companies' analysis of getting into a clinical trial.

I guess I'm saying all this because there are many reasons now to be more optimistic than ever, but, as Jeebs said up above, we've been through a "maddening (and then some) history of false starts," so I am trying to temper my optimism. 

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