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JF_RegenicaBio

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JF_RegenicaBio last won the day on August 28

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About JF_RegenicaBio

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  1. JF_RegenicaBio

    Open letter to major chemical companies (BOL-148)

    Read articles like those with a grain of salt- the journalists sometimes are the ones who are getting rich off of us (and our emotions). Also, here is how I see the money thing: As long as they bring us good medicines, we can work together to compensate the innovators. (And when a price gets too high, we can work together to get them lowered). I don't know about the billionaire couple or any switch from non-profit to for-profit, but I do know that Compass seemed aboveboard when we spoke (although not too interested in Cluster). We planned to follow up in 3 months, but it does seem like they would only be open to a carve out if I put cash on the table, which is not typically how I do business with licenses+acquisitions (at this point in my career). I still want to get access to BOL for you all but the person I was told holds the patents has no interest in collaboration or development. If anyone can put me in touch with the current company holding the BOL torch I really believe that I can conduct the preclin necessary to file an IND and get that into an expanded access program so you all can get it safely+legally (and quickly). I have contacts at Johns Hopkins and Yale and Cluster is really compelling- maybe they could initiate some studies if we were to submit a joint proposal to NIH or something. I just need more info on the current state of BOL. I'm heading to the U.K. on 11/9 to discuss collaborative research and development and to explore whether we can set up a small operation on behalf of my company in England. I'll meet with DSTL at Porton Down, the CEO of Salisbury NHS Trust, and Public Health England (PHE). If any of you have questions or concerns that I can reiterate on your behalf, please don't hesitate to shoot me an email (jfernandes@regenicabio.com). I'll then meet with BARDA and the FDA on 11/21, to discuss an antidote that we want to develop for children and agricultural workers who are poisoned by pesticides in the (mostly in the developing world). Again, if there are any small questions (these meetings are more specifically geared to antidotes) please let me know. I wish I had more resources to help. What I do have right now are great relationships, tenacity+persistence, and the desire to figure out some creative solutions for my friends, the clusterheads. Onward, -J
  2. JF_RegenicaBio

    Open letter to major chemical companies (BOL-148)

    We must be on same wavelength- I was just about to post a small update. Although I have no updates regarding BOL-148, I have gone back and forth with a company called Compass Pathways. There is an NDA in place, so can't disclose anything much. Will say that we are scheduled to chat more extensively on 9/18. I will also say that they have been developing psilocybin for use in treatment resistant depression and have enrolled a Phase IIb. I have heard psilocybin could be very promising for a certain group of patients. Will see what can be done.
  3. JF_RegenicaBio

    Open letter to major chemical companies (BOL-148)

    Thank you for the welcome. I really hope to attend a CH conference in SoCal sometime soon. I have alot to learn as a rare disease advocate but can sense that the community here is really something- I hope take any lessons learned to other communities of those w/rare disorders who don't yet have infrastructure/unification. Money is the top impediment to getting drugs to patients. It feels as if all I do is fundraise so I understand/empathize w/ the struggle. Very promising NMDA partial agonist (like ketamine, without psychotomimetic effects). Replaced by Apimostinel which is under dev by same companies (Allergan+Naurex) as we speak. Not familiar w/Joe Moskal but sounds like an amazing connection and scientist. Would love to pick his brain. Thank you for the note- It's a pleasure to learn from you all and want to do anything I can to help.
  4. JF_RegenicaBio

    Open letter to major chemical companies (BOL-148)

    I have read the compilation and have shared with friends. Unbelievable and heartbreaking. Very grateful that you shared. I really hope we can figure out a way to facilitate some kind of access program to the 5ht2a drugs that seem to work in CH. Dealing with Sched-I is difficult but nothing is impossible. I reached out to the CEO of Savant HWP who presumably now holds the BOL Patents, and will hopefully hear back from him. In meantime- does anyone have experiences with the newly approved Alcanezumab-gnlm (Emgality)? I would love to hear. Hopefully it provides some with relief. Edit: P.S. I am sorry to hear about Entheogen. It was irresponsible for them, in my opinion, to try and crowdfund a trial (if that is what happened). A full preclin program, necessary for BOL (multi species- ADME, GLP tox, CMC scale up, etc.) could cost millions before a single patient could be allowed to take a single dose in a trial. This is not to say there are not other ways to get the drug into the hands of patients, ASAP.
  5. JF_RegenicaBio

    Open letter to major chemical companies (BOL-148)

    Thank you for that- I look forward to reading/learning more from the experiences that have been shared on this forum. I had the chance to speak by phone with Bob earlier today, and he seems like a great advocate (one with alot of insight and years of experience). He shared some really interesting stories with me. Some we laughed about, but others left me feeling really frustrated over the unique challenges faced by the CH community (like about those who lack access to sustainable prophylactic options and also score high on tests for PTSD, or elderly CH patients who struggle to access oxygen as a treatment). Following our call, Bob told me he would put me in touch with the clinicians at Yale running a CH psilocybin study, and that he would introduce me to the individual out here in California who I think Bob said holds the BOL-148 patents and is trying to put things together for some preclin efforts. I look forward to helping wherever I can and will post on the forum as things unfold. -J
  6. JF_RegenicaBio

    Open letter to major chemical companies (BOL-148)

    Thank you all for the responses and welcome. I am in touch with Bob and setting up a call to discuss the current status of the 2-Bromo-LSD program. At the very least, perhaps I can try and hold this new company accountable alongside you all and analyze things with you as they progress. There are a number of reasons why CH is personal to me and I'm happy to share more by pm. Broadly- I strive to be an advocate for those with debilitating disorders that have been abandoned by big pharma. My mother suffers from a serious disease with no adequate treatments, with a similar patient population to CH. I appreciate the kind words, but also can imagine and relate to your frustration. I have heard stories about Entheogen. I'm not here to bring false hope and have no clue if I can help. I'm just a patient advocate with a creative approach to drug development, a growing understanding of how the FDA works in practicality, and a team that is much smarter than I am.
  7. JF_RegenicaBio

    Open letter to major chemical companies (BOL-148)

    Apologies for bumping an old thread, but want you all to know that CH has become personal to me. I am the CEO and founder of a biopharmaceutical company in San Diego, and, although the company is primarily engaged in developing antidotes for the U.S. Military+Emergency Preparedness, I am a strong advocate for underserved patient populations (where traditional pharma is unable or unwilling to help). We may have access to resources and partners that can push this compound to a place where you all can access it safely, affordably, and reliably. I'd love to continue the dialogue and see where I/we can be of assistance and get this drug in the hands of patients as quickly and efficiently as possible. Please email jfernandes@regenicabio.com if you're interested in discussing further. Strength and Optimism, -Jack
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