More from the company presentation.
And right now, the company has several potential catalysts that could spark vertical chart growth near term. Here's what you need to know...
No. 1 MYCOF Potential Breakout Catalyst - Positive Meeting With The FDA
Mydecine Reports Positive Pre-IND Meeting With FDA For MYCO-001 Smoking Cessation Study
Company rapidly prepares to submit IND and Breakthrough Therapy Status Applications
DENVER, March 01, 2022 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced a positive meeting with the Food and Dr-ug Administration (FDA) regarding their Investigational New Dr-ug (IND) and breakthrough therapy status applications.
The Company reported a meeting with the FDA on February 28th to review their IND application to administer MYCO-001, in combination with therapy, to humans as part of smoking cessation treatment. Leading dr-ug and substance abuse researcher, Dr. Matthew Johnson of Johns Hopkins University, will serve as the lead investigator for this multi-site study.
“The data from John Hopkins University’s ongoing studies assessing psych-e-delic-assisted therapy to treat nic-o-tine addiction is showing efficacy rates 2-3 times higher than the current gold standard of treatment. Our team is eager to start collecting the data needed to bring an approved dr-ug product to market that could potentially save millions of lives,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly.
"Mydecine plans to submit a request for Breakthrough Therapy designation with our IND submission. Psi-lo-cybin-assisted therapy has shown meaningful advantages over available medications for to-ba-cco addiction including significant increases in safety and efficacy. We are looking forward to closely working with the FDA to bring safer and more effective therapy to the millions of people who are trying to quit smoking across the globe,” said Mydecine’s Senior Director of Clinical and Regulatory Affairs, Jessica Riggleman.
“We had an extremely positive meeting with the FDA in regards to our proposed smoking cessation study. The FDA provided helpful feedback on our study design that we will implement. We are now working rapidly in preparing our IND submission for the 2B portion of the study which we believe will be next month. Once cleared, we will move swiftly into patient recruitment. This is a study we have been diligently working on over the last two years and we’re excited to continue moving it forward,” said Mydecine CEO Josh Bartch.
Read the full article here.
No. 2 MYCOF Potential Breakout Catalyst - Company Now About To Supply cGMP Products
Mydecine’s Exclusive Dealer Identified as Licensed Psi-lo-cybin and MD-MA Supplier in Canada
Mydecine now able to supply cGMP products to healthcare providers for patients with serious and life-threatening conditions through the Special Access Program
VANCOUVER, British Columbia, Feb. 08, 2022 (GLOBE NEWSWIRE) -- Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced that Health Canada has included the dealer’s license Mydecine operates under as a supplier for the Special Access Program, which allows healthcare providers to request specific dr-ugs for approved patients who have not responded to other available treatment options.
The licensed dealer facility, available to Mydecine through its exclusive agreement with Applied Pharmaceutical Innovation (API), contains a unique research and development infrastructure as well as a manufacturing facility in Edmonton, Canada. With the license, Mydecine is able to provide psi-lo-cybin and MD-MA that meet Current Good Manufacturing Practices (cGMP) through Health Canada’s Special Access Program (SAP). This program allows practitioners to request psi-lo-cybin and MD-MA for a patient with a serious or life-threatening condition where conventional treatments have failed, are unsuitable, or are generally not available in Canada.
“While we will continue to advance the research of psych-e-delic-assisted psychotherapy through our clinical trials and dr-ug development process, we understand there are patients in need of treatments today. Through our dealer’s license, we can offer psi-lo-cybin and MD-MA to practitioners and clinics in Canada who want to offer these treatment options for patients in need,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly.
Read the full article here.
No. 3 MYCOF Potential Breakout Catalyst - Signing Of A Game-Changing LOI With The Newly Institute
Mydecine Signs LOI with The Newly Institute to Provide Psych-e-delic-Assisted Psychotherapy to Patients under Health Canada’s Special Access Program
Under Mydecine’s recently announced Special Access Support and Supply Program, the Company will supply cGMP Psi-lo-cybin and MD-MA to The Newly. The companies will partner to co-develop protocols, therapy manuals, and training needed to treat patients who need specific care.
VANCOUVER, British Columbia, Jan. 18, 2022 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today announced it has signed a Letter of Intent (LOI) with The Newly Institute Inc. (“The Newly”), a Calgary, Alberta based company opening private inter-disciplinary mental health clinics across Canada, to collaborate on expanding psych-e-delic-assisted psychotherapy to patients.
The Newly offers rapid access outpatient programs providing innovative mental health, addiction and trauma therapies. The Newly opened its first location last year in Calgary and intends to open additional clinics in cities across Canada beginning in 2022. Mydecine and The Newly have world-class teams of medical and scientific experts positioning their companies to provide the highest quality and most responsible care to patients. Together, the companies will create the package of resources needed for patients and practitioners to successfully gain acceptance into Health Canada’s Special Access Program (SAP).
The Newly is the first partner under Mydecine’s recently announced Special Access Support and Supply Program (SASSP). The companies will develop protocols and therapy manuals for a variety of indications. Mydecine will provide cGMP psi-lo-cybin and MD-MA alongside the safety and efficacy data needed to gain acceptance into Health Canada’s SAP. The Newly will provide the clinic locations and experienced therapists needed to perform the treatments. The companies intend to enter into a revenue sharing agreement.
Mydecine Chief Medical Officer Dr. Rakesh Jetly said, “The recent changes to Canada's SAP program are encouraging, but in order to make a significant positive impact on patients, we need to ensure these therapies are carried out safely and effectively. We are excited to work hand-in-hand with The Newly team to develop the evidence-based protocols, therapy manuals, training and other resources physicians need in order to promote the successful integration of these treatments into their existing infrastructure."
Read the full article here.
No. 4 MYCOF Potential Breakout Catalyst - Oversold Leaning Technicals Could Be Signaling Reversal Potential
As of close on Thursday, Barchart was reporting this profile to have several oversold leaning technicals.
These technicals could be signaling a healthy reversal in the near term.
Here's the definition of a "reversal" from Investopedia:
"A reversal is a change in the price direction of an asset. A reversal can occur to the upside or downside. Following an uptrend, a reversal would be to the downside. Following a downtrend, a reversal would be to the upside. Reversals are based on overall price direction and are not typically based on one or two periods/bars on a chart."
Now, here are some of the key technicals (as of close Thursday) that could signal MYCOF to be leaning oversold and on the verge of a potential reversal.
- 9-Day Relative Strength Index: 30.69%
- 14-Day Relative Strength Index: 35.14%
When these numbers drop down to the 30% range and lower, they can be viewed as being in oversold territory. While in this territory, they can paint the picture of a profile that is undervalued.
- 14-Day Raw Stochastic: 10%
- 14-Day Williams %R: 90%
As the Raw Stochastic nears the 10% range and lower and the Williams %R nears the 90% range or higher, these technical indicators may also be viewed as oversold and undervalued.
Keep an eye on these technicals closely.
No. 5 MYCOF Potential Breakout Catalyst - Major Supercomputing Breakthrough
Mydecine Achieves Innovative Supercomputing Artificial Intelligence Modeling in Psych-e-delic Dr-ug Development Enabling Quick Screening of Billions of Compounds
The new serotonin receptor model (5-HT2A) will allow the Company to rapidly increase dr-ug analysis promoting near-term patent filings for novel psych-e-delic molecules.
DENVER, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, announced today they have completed a target-based model of the classic psych-e-delic serotonin receptor 5-HT2A for use in their AI-driven dr-ug discovery program. The new model will allow them to expeditiously screen billions of structures to determine which novel compounds are most likely to increase binding affinity, enabling them to continue creating improved second and third generation psych-e-delic molecules for medical use.
By centering their dr-ug discovery efforts around artificial intelligence (AI) and machine learning (ML), Mydecine is positioned to discover dr-ug enhancements more cost effectively and more efficiently than their competitors. Using AI technology is relatively new in the dr-ug development space and its applications are continuously expanding. The goal of this technology is to eliminate, or drastically reduce, the manual efforts companies typically undergo to identify possible dr-ug improvements. By filtering the dr-ug candidates with AI, the Company is inherently making their investments in later stage dr-ug development more valuable by eliminating potential candidates that are likely to fail early on in the process.
Without AI and ML, based on their hypotheses, companies have to manually synthesize each molecule and individually test the likelihood of a successful binding agent. This process can consume enormous amounts of time and money; therefore, efficiently eliminating candidates likely to fail in preference for candidates that are more promising is extremely valuable.
“AI gives us an incredibly robust tool for screening potential novel psych-e-delic compounds. This screening gives us increased confidence in investing in the later stages of our dr-ug development and enables rapid development in our pipeline,” said Chief Science Officer Rob Roscow.
Read the full article here.
MYCOF Potential Catalysts Recap - Key Details To Know Now
No. 1 - Positive Meeting With The FDA
No. 2 - Company Now About To Supply cGMP Products
No. 3 - Signing Of A Game-Changing LOI With The Newly Institute
No. 4 - Oversold Leaning Technicals Could Be Signaling Reversal Potential
No. 5 - Major Supercomputing Breakthrough
Coverage is officially reinitiated on MYCOF. When you have time, do this: