Zhittya Regenerative Medicine Reports & Reviews (2)
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SCAMPULSE
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Type of a scam Healthcare/Medicaid/Medicare
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Here it is:
On Friday, May 4, 2018 8:08 PM, Zhittya Regenerative Medicine wrote:
Zhittya Regenerative Medicine, Inc.
Notice of Events in May Relating to Parkinson’s Disease
Seminar in Arizona & Las Vegas Meeting
Dear Person Interested in Parkinson’s Disease:
We are trying to meet people who understand Parkinson’s disease, including patients who suffer from this disease, as well as their caregivers and medical support professionals. Our reasons are simple - we are trying to learn more about things we need to know.
No one has ever conducted a human clinical trial to infuse the FGF-1 molecule into patients to attempt to treat Parkinson’s disease. We are therefore exploring new drug discovery territory. From talking to sufferers and caregivers in Florida, California, Arizona and other states, we have learned many things, and some of this knowledge has already been incorporated into the design of our clinical trials – things which we believe might enhance the success of our clinical trials.
We would not be planning upon expending millions of dollars in these clinical trials to treat Parkinson’s disease if we did not believe our drug is safe and could produce positive improvements for Parkinson’s disease sufferers. What we do know, is that if we do not learn everything we can about how to enhance the possible outcomes in our clinical trials, that we may make mistakes which could delay our trials leading to people suffering more than needed. I truly believe our drug will work in treating Parkinson’s disease, and what we are trying to do now is to come up with the best designed clinical trial as possible. You know more about Parkinson’s disease than we do.
I would like to thank the people in Arizona who have been so helpful in providing us with their concerns, ideas and directions. Caregivers have given us a real world and experienced realization of how best to achieve our desired outcomes. It is interesting to me that for all of the medical professionals we have talked to who deal with patients with Parkinson’s disease, very few of them, in my opinion, appreciate the harsh realities and real issues that people with this disease face. I hate to say this, but doctors who treat these patients in their office and then go home for a nice relaxing dinner, miss a lot of the practical issues faced by patients with Parkinson’s disease and their caregivers. I feel strongly that we need to learn everything we can about the harsh realities and real issues with this disease, so we can enhance our clinical trials for Parkinson’s disease.
To those caregivers in Arizona who told me hard truths about the reality of this disease, I thank you. We have added three material changes to our clinical trial protocol design based on your suggestions. These changes we had never even considered until you brought it up, but it now seems like such an obvious improvement. Again, thank you, and I believe many times in life the difference between success and failure, is when you miss the obvious.
Phoenix Meeting
From the overwhelming interest we have had in Arizona, we are going to host an Informational Seminar on May 22, 2018 at Rock Steady Boxing, *** ** *** *** ** *** *** starting at 2:00 PM.
Many Parkinson’s disease sufferers from all over the country have told us about their personal involvement with the Rock Steady Boxing exercise program to deal with their Parkinson’s disease symptoms and that they have had a positive experience. We have decided we want to learn more about this exercise program to deal with Parkinson’s disease. Coach Landon Vance, the owner of the Rock Steady Boxing affiliate in Mesa, Arizona, as well as many of the patients who exercise at his facility, have been extremely helpful to us. We want to learn more about the state of mind and quality of people who have decided to fight Parkinson’s disease by being physically active. We also want to understand if positively committed people are better candidates for our clinical trials.
Dr. Jacobs, John Laub and I will attend the May 22nd seminar and discuss the latest on the medical evidence and the plans for our drug to treat Parkinson’s disease. We will stay as long as needed to answer any questions you have. From our past seminars, we have learned so much from the question and answer period following the talk. Until you know what you do not know, you cannot fix it!
If you wish to RSVP for this event please use this link: goo.gl/PdXr2e
Sitting is very limited so please RSVP, as I fear we will exceed the room’s capacity.
IMPORTANT--THIS PRESENTATION IS NOT MEANT TO BE A SCREENING SESSION FOR POTENTIAL PATIENTS FOR OUR CLINICAL TRIALS FOR PARKINSON’S DISEASE.
From an earlier email I sent out, many people replied they would fly from Seattle, Chicago, London and Kuwait to our seminar in Phoenix, Arizona to be screened to be in our clinical trial for Parkinson’s disease. They misread and misinterpreted what I had written. The meeting in Phoenix is simply another informational meeting, similar to the ones we had in West Palm Beach, Palm Springs, Las Vegas and in five locations in the greater Los Angeles area. We are exploring additional meetings for INFORMATIONAL PURPOSES ONLY in San Diego, New York City, Atlanta, several sites in Florida and elsewhere. Again, these information meetings are not screening sessions for the clinical trials.
Until we file our Investigational New Drug (IND) application with the US FDA for the Parkinson’s disease indication and receive back their reply, we do not yet know what the final “inclusion and exclusion criteria” will be for our clinical trial. I know you all want to be cured now. We are flooded with emails, calls and more requesting, even demanding, that we treat them now. We have to follow US FDA standards exactly, no tricks, no short cuts and no foolishness.
I know you are suffering, and I also know that if we are right and our drug is safe and provides benefit to Parkinson’s disease sufferers, we may help a million people in the US and maybe 25 million people worldwide. I also believe if our clinicals trials are successful for Parkinson’s disease, we may verify our belief that many other neurodegenerative diseases, including Alzheimer’s disease, stroke, dementia, aging and more can be treated by our drug. We cannot risk doing anything Stupid that would jeopardize a possible approval by the US FDA. A six- month delay in our drug to treat Parkinson’s disease is better than never having a treatment, because we were sloppy with our initial clinical trials. In my 50 years of doing business, if there is one thing I know I can do extremely well, it is I can make mistakes. We want to minimize the mistakes we make, because those mistakes will cause delays. Better the drug is approved in 18 months to treat people with Parkinson’s disease than 7 years. It would be a crime if the delay was because I made sloppy, stupid mistakes. Please help me not to make stupid mistakes.
When we know the FDA-approved criteria for patients to enter our clinical trial, we will email each of you. At that time, we will start to screen those people who meet these criteria as possible candidates for our trials. It will not be done in secret or behind your back. We want the best candidates for the trials, so we have the best chance to succeed. My hope is that by July of this year we can begin our screening process.
Las Vegas Money Show-May 14th to 16th
Since we are based in Las Vegas (as refugees from California state taxes), several people who are following our progress with Parkinson’s disease have contacted us to inform us that they will be attending the Annual Money Show in Las Vegas, from May 14 to the 16th. This meeting of investors attracts around 4,000 attendees and I have been attending these Money Show events for decades. Those people who have written us have asked if they could meet with us while they are here in Las Vegas attending the conference and I am happy to meet with them, even if it is just for coffee (my treat!). If you will be attending, please let me know and my personal email address is ***. As we are now setting up many meetings with our investor friends who will be at the meeting, our schedule is getting filled up, so the sooner you contact me the more likely it will be that we can schedule time to meet.
Conclusion
We are continuing our “Informational Seminar Meetings” and we seek to meet more people and learn about new issues and ideas.
We believe our drug will be safe and beneficial to Parkinson’s disease sufferers. However, our belief does not matter, as we have to prove to the US FDA that our drug is safe and benefits Parkinson’s disease sufferers. This process is complex, expensive and demanding. Delays are a constant reality of drug development.
I have been working on this molecule for 20 years and we have already achieved remarkable success in treating coronary artery disease, diabetic foot ulcers, venous ulcers and peripheral artery disease. To now be on the verge of hopefully extending this success to treat degenerative brain diseases such as Parkinson’s disease, is something that is very exciting for us and something we take very seriously. Smart business would be to get our drug approved for the diabetic foot ulcer indication and then use the profits from that drug to fund the riskier drug development programs for brain disorders. We have decided that the need for a treatment for Parkinson’s disease is too great for us to play it safe. We believe we have something to treat Parkinson’s disease and we are going for it now. Do not assume that we know everything about Parkinson’s disease, so make sure we understand the issues, so we do not lose time. When you explore uncharted territory, find a guide who knows the lay of the land and speaks the language of the natives.
If you have ideas and comments, we are very open to guidance. I really hate to make stupid mistakes.
Sincerely,
Dan Montano
CEO of Zhittya Regenerative Medicine