Hi folks I hope you are well in this awful place we find ourselves. I have recently received an update about the drug and if you read it you can understand the delay. I will reiterate what Dr. Jacobs and Dan say so please use this as hope and do not contact anyone regarding the trials. If its successful we will know about it so its for information only.
Love to all Jerry

Hello, this is Dr. Jack Jacobs.

I know this is an anxious time and that most of you are waiting for an UPDATE on the status of the Parkinson’s disease clinical trial.

As you know, we are attempting to develop a novel treatment for Parkinson’s disease. We are advancing a new pharmaceutical agent (human FGF-1) that has never been utilized to treat diseases in the brains of patients before. The FDA has a responsibility to request items relating to the safety of the drug for this “first in humans” utilization. Many highly complex and integrated issues must be addressed to satisfy the FDA’s safety concerns before we get the final permission to proceed with our clinical trial for Parkinson’s disease. Once we have resolved these issues, then the same safety data can be utilized to advance our clinical trials with other neurodegenerative diseases, including amyotrophic lateral sclerosis ALS, Alzheimer’s disease, multiple systems atrophy (MSA), multiple sclerosis (MS) and stroke recovery.

We understand that many of you want to learn as quickly as possible if we have a treatment for these neurodegenerative diseases. We are attempting to design the best studies to resolve complex technical issues, issues which no one has ever had to address before. The FDA, equally, is confronted with items (questions), it has never asked before, and it takes time to clarify what is the right way to obtain the needed answers. Some of our followers have gone so far as to contact the FDA on our behalf, but unfortunately, these actions only cause stress in our relationship with our regulators and could delay us even more. Please do not contact the FDA regarding our clinical trials.

Quiet Period

For a variety of reasons, we will be entering a “quiet period” were we will limit our communications to everyone, as we move forward with the additional testing being required by the FDA. We do not know if that quiet period will be 2 months or 6 months. We will continue to give presentations on data which has already been made public, but please accept that as soon as we can, we will update you with any new information we can share with you. We appreciate your understanding of our need to go quiet and look for your continued support.

Events Schedule

We had a strong response at the Orlando MoneyShow, which we attended in February 2019, and at the Las Vegas MoneyShow, which ran from May 13th-15th. At our Las Vegas presentations, we had over 700 people attending our presentations on the different drugs we are developing. Zhittya will be at the Seattle MoneyShow, June 15th-16th at the Hyatt Regency Hotel, Seattle and at the San Francisco MoneyShow, August 15th-17th at the Hilton Hotel, San Francisco Union Square. If you wish to attend those events, there is no cost. You simply have to register with the Money Show and they will send you a free ticket. On the web site for the MoneyShows, you can see the agenda for each of the shows and also the days and times when we will be giving our presentations.

Again, those dates are:

Seattle: June 15-16 at the Hyatt Regency Hotel

San Francisco: August 15-17 at the Hilton San Francisco Union Square

Additionally, Zhittya will have a presentation on our drugs at the Freedom Fest, July 17th through the 20th at the Paris Resort, Las Vegas, Nevada. If you are attending the Freedom Fest, please consider coming to our presentation. I also want to make you aware that there is a Convention Fee to attend the Freedom Fest. The Freedom Fest requires that you be a paid participate to their event to attend our presentation.

Webinar of the Presentations from the Las Vegas MoneyShow: May 13th -15th at Bally’s/Paris Hotel

Many people have asked us to come to their area and give them presentations on our medical hypothesis, clinical data and possible treatment for the medical indications we are pursuing. The MoneyShow in Las Vegas videotaped six (6) of our presentations and those presentations are available on YouTube at the links provided below for you to view and share. Some of the presentations have new content from the Updates we have been sending out, including new information on using our drug as a possible treatment for multiple sclerosis (MS). In addition, topics we have discussed in the past, but you may have missed are presented in these six videos, including a discussion on using our drug to treat “women’s small vessel heart disease”, the number one cause of death for women in the U.S.

I hope you find these presentations beneficial and please feel free to share them with others.

Presentations and Their Links:

Dr. Jack Jacobs Using Biotech to Conquer Human Diseases

Link: https://youtu.be/TIZms9V584I

Ms. Viktoriya Montano Why Does Heart Disease Kill More Women than Men
and How Can Biotech Address This?
Link: https://youtu.be/_7ACGAgcDGA

Mr. Dan Montano Investing in Biotech: Important Concepts to Succeed!
Link: https://youtu.be/6JGohtcs2U0

Dr. Jack Jacobs Angiogenesis in the Brain to Reverse Parkinson’s
Disease, Alzheimer’s Disease and More.
Link: https://youtu.be/z1pDtOdZrTA

Ms. Viktoriya Montano New Drugs for Diseases that Affect Women
Link: https://youtu.be/0yi1-Pdf6NI

Dr. Jack Jacobs New Frontiers in Healthcare: Disease Reversal Through Angiogenesis
Link: https://youtu.be/2xcF1YnY_ng


Dan Montano here.

Our entire team suffers every day that we are delayed in advancing our hoped-for treatment for your diseases. We know that we personally do not suffer like the people with these diseases, or their caregivers. However, we have met so many of you and we have dear friends dealing with these diseases and we do care. We are trying everything we can to move these drugs along as quickly as possible and we understand time is your enemy.

We are now entering a period of time where we have to be very careful with what we say and do. We cannot share with you our discussions with regulators, our actions to resolved these items, or even predict the outcomes or the timing of those items. I can state, however, that we see nothing we believe we can not address, overcome and then move forward.

The animal toxicity trial the FDA wants us to provide them will cost just under $1 million dollars. It will take months to conclude. This animal trial is critical to us to advance to the next step. We need to confirm every aspect of that trial with the FDA, so the animal trial we conduct has everything they want and exactly in the way they want it. We do not want to spend months and a million dollars to learn we did not address with a complex blood test a possible X, Y or Z toxicity in the animals.

We are very busy advancing many items simultaneously that we cannot share with you at this time. Please be patient with us during this brief “quiet period.” I am confident that when we get to the other side you will be pleased with us and understand the need for us to be quiet now.

I want to thank the thousands of you who pray for us and our efforts. We are working feverishly to advance what I believe is the biggest medical breakthrough of the last 100 years. Just as penicillin and other anti-microbial drugs enhanced the human battle against tuberculosis, syphilis, pneumonia, cholera and more, turning these incurable death sentences to treatable diseases, and thereby extended human life expectance from 35 years in 1918 to now 77 years, I hope our work changes today’s incurable diseases, such as diabetes, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, ALS and more into treatable disease and thereby add another 20 to 30 years of quality life to each of us. Since I turn 71 in July, I believe 20 or 30 additional health years is a good thing! As a California “baby boomer” I can not express my displeasure that our songs of “Forever Young” seem not to be coming to pass.

Ladies and gentlemen, we are making great progress and we need and want your support, but please leave us now to carry on the next steps of our journey to see if we are right or wrong.

Dan Montano

Attachments area
Preview YouTube video Using Biotech to Conquer Human Diseases | Jack Jacobs

Using Biotech to Conquer Human Diseases | Jack Jacobs
Preview YouTube video Why Does Heart Disease Kill More Women than Men and How Biotech Can Address This?

Why Does Heart Disease Kill More Women than Men and How Biotech Can Address This?
Preview YouTube video Investing in Biotech Important Concepts to Succeed | Daniel Montano

Investing in Biotech Important Concepts to Succeed | Daniel Montano
Preview YouTube video Angiogenesis in the Brain to Reverse Parkinson's Disease, Alzheimer's Disease and More

Angiogenesis in the Brain to Reverse Parkinson's Disease, Alzheimer's Disease and More
Preview YouTube video New Drugs for Diseases That Affect Women | Viktoriya Montano

New Drugs for Diseases That Affect Women | Viktoriya Montano
Preview YouTube video New Frontiers in Healthcare: Disease Reversal Through Angiogenesis | Jack Jacobs

New Frontiers in Healthcare: Disease Reversal Through Angiogenesis | Jack Jacobs

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