[VictorMasonIsRight]

20,000 buyer at the close bumped it up $1.25/ share hmmm

[Paulness]

NEWS -- Relmada Therapeutics Solidifies its R&D Leadership Team with the Appointment of Marc de Somer, MD, MBA, ScD, MPH, MSc, as Senior Vice President, Clinical Development and Safety

NEW YORK, March 31, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced the appointment of Marc de Somer, MD, MBA, ScD, MPH, MSc, as Senior Vice President, Clinical Development and Safety. Dr. de Somer will oversee Clinical Development and Safety at Relmada. He has over 30 years of experience in global clinical development strategy, design, execution, and evaluation.

Dr. de Somer joins Relmada from Prilenia Therapeutics, a privately-held, clinical-stage biotechnology company focused on developing treatments for neurodegenerative and neurodevelopmental disorders, where he served as Chief Medical Officer (CMO). He was responsible for clinical R&D strategy, tactical leadership and management from translational medicine to full development and regulatory interactions. Previously, Dr. de Somer served as VP of Clinical R&D & Medical Affairs at leading CNS-focused biotechnology companies, Voyager Therapeutics and Alkermes, and also was VP Neurology at PPD Biotech, a prominent clinical research organization. In these roles, he was responsible for numerous pre-IND to NDA interactions with U.S., European and Japanese regulators. During the course of his career, Dr. de Somer's clinical leadership has resulted in global regulatory approvals of several drugs, including Exelon® in Alzheimer's dementia, Comtan® and Stalevo® in Parkinson's disease, Differin® in dermatology, Artistada® in schizophrenia, and he is a co-inventor of apomorphine sublingual film (acquired by Sunovion and currently undergoing NDA review) in late-stage Parkinson's disease, as well as Miacalcin® in post-menopausal osteoporosis and Sandimmune® Neoral® in organ transplantation. Earlier in his career, Dr. de Somer co-founded three venture capital-backed clinical-stage neuroscience start-ups where he served as CMO and EVP R&D, with two successful mergers and acquisitions (M&A) exits. Prior to this, he had leadership responsibilities in Europe, UK and U.S. of clinical line functions and projects at Sandoz/Novartis Pharmaceuticals.

Dr. de Somer earned an MD from Brussels Free University, Belgium, a doctorate from the Institute of Tropical Medicine in Antwerp, Belgium, an MSc in biostatistics (a joint program of Harvard School of Public Health, Imperial College London, and Leuven/Hasselt University, Belgium), and an executive MBA from Columbia University Business School. Additionally, he has an MPH, a postgraduate degree in epidemiology and an MSc in pharmaceutical medicine.

"Marc has led the development of multiple marketed CNS drugs during his prominent career," said Thomas Wessel, Head of R&D at Relmada. "We are thrilled to have someone with his vast knowledge of the CNS field, extensive clinical trial management experience and substantial regulatory expertise join our team. We are now planning for our first pivotal Phase 3 study of REL-1017 as an adjunctive treatment in patients with major depression to start in the second half of this year, and Marc's contributions to study design and execution will be critical."

"I am very excited to focus on maximizing our probability of success, defeating placebo response and excessive noise to demonstrate the true therapeutic signal with the necessary accuracy, precision and replicability. I look forward to working with the Relmada team, as we effectively conduct clinical trials to provide the highest quality of information and therapeutic value for patients, prescribers, payers and shareholders." said Dr. de Somer. "I look forward to contributing to de-risking development of REL-1017 in MDD, and additional indications and programs, as we build our pipeline and team."

About dextromethadone (REL 1017)

Relmada is currently developing dextromethadone as a rapidly acting oral agent for the treatment of depression. Working as an NMDA receptor antagonist and on the same binding site as ketamine but having shown no ketamine psychotomimetics side effects, dextromethadone is fundamentally differentiated from all currently FDA-approved antidepressants, as well as all atypical antipsychotics used adjunctively. In April 2017, the FDA granted Fast Track designation for dextromethadone for the adjunctive treatment of major depressive disorder.

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a clinical-stage, publicly traded biotechnology company developing novel medicines to address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. Relmada's lead program, dextromethadone (REL-1017), is an N-methyl-D-aspartate (NMDA) receptor antagonist in development for the treatment of depression. NMDA receptor antagonists may have utility in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.

Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to" and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.

Investor Contact:

Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://[e-mail]

For Media Inquiries:
FischTank Marketing and PR
mailto://[e-mail]

View original content to download multimedia: http://www.prnewswire.com/news-releases/relmada-therapeutics-solidifies-its-rd-leadership-team-with-the-appointment-of-marc-de-somer-md-mba-scd-mph-msc-as-senior-vice-president-clinical-development-and-safety-301032481.html

SOURCE Relmada Therapeutics, Inc.

[VictorMasonIsRight]

Strange day, 5 up days MACD breakout ( lower right crossing) didn’t happen.
In sympathy w AXSM and SAGE ? No relation to RLMD

https://stockcharts.com/h-sc/ui?s=RLMD

[Paulness]

NEWS -- Relmada Therapeutics Strengthens Scientific Leadership Team with the Appointment of Judy Caron, Ph.D., as Vice President of Drug Development

NEW YORK, March 24, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced the appointment of Judy Caron, Ph.D., as Vice President of Drug Development. Dr. Caron has 30 years of experience in biopharmaceutical development.

Dr. Caron joins Relmada from Neurana Pharmaceuticals, a privately-held, clinical stage, biopharmaceutical company focused on the treatment of neuromuscular conditions. Dr. Caron co-founded the company in 2012 and served as Chief Operating Officer (COO) and Head of Clinical Development. Her responsibilities included project management, clinical development, chemistry and pharmaceutical development, and regulatory operations. Previously, Dr. Caron was COO and a partner at BioNevia Pharmaceuticals, LLC, from 2008-2014. Prior to this, she served in increasingly senior drug development-related roles as Vice President CNS Program Director at Sepracor Inc from 1997-2008. At Sepracor, Dr. Caron directed several CNS projects, including the development and approval of Lunesta® in the U.S. and Japan. She began her career at Sandoz Pharmaceuticals where she was Project Coordination Manager. Dr. Caron holds a Ph.D. in molecular genetics from Emory University, an M.S. degree in genetics from Ohio State University and a B.S. degree in biology from Cleveland State University.

"Dr. Caron has extensive CNS drug development experience," said Thomas Wessel, Head of Research and Development at Relmada. "We are thrilled to add someone of Judy's caliber to our senior management team. Dr. Caron will be an instrumental team member to further advance REL-1017 in the clinic. This agent has the potential to become an important oral and rapid-acting adjunctive treatment in patients with major depression, and Judy will provide critical support to our team for the next steps in clinical development and the regulatory review process."

"I am delighted to join Relmada to continue the development of REL-1017, which could offer a compelling new treatment option to the millions of patients suffering from depression," said Dr. Caron. "REL-1017 has previously shown rapid, statistically and clinically meaningful antidepressant activity, in conjunction with a favorable tolerability and safety profile. I look forward to working with the Relmada team to further evaluate this promising drug candidate in late-stage clinical trials."

About dextromethadone (REL 1017)

Relmada is currently developing dextromethadone as a rapidly acting oral agent for the treatment of depression. Working as an NMDA receptor antagonist and on the same binding site as ketamine but having shown no ketamine psychotomimetics side effects, dextromethadone is fundamentally differentiated from all currently FDA-approved antidepressants, as well as all atypical antipsychotics used adjunctively. In April 2017, the FDA granted Fast Track designation for dextromethadone for the adjunctive treatment of major depressive disorder.

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a clinical-stage, publicly traded biotechnology company developing novel medicines to address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. Relmada's lead program, dextromethadone (REL-1017), is an N-methyl-D-aspartate (NMDA) receptor antagonist in development for the treatment of depression. NMDA receptor antagonists may have utility in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.

Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to" and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.

Investor Contact:

Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://[e-mail]

For Media Inquiries:

FischTank Marketing and PR
mailto://[e-mail]

View original content to download multimedia: http://www.prnewswire.com/news-releases/relmada-therapeutics-strengthens-scientific-leadership-team-with-the-appointment-of-judy-caron-phd-as-vice-president-of-drug-development-301028890.html

SOURCE Relmada Therapeutics, Inc.

[VictorMasonIsRight]

Is BTD delayed by Wuhan400? probably,
market decline NOT due to the presidential press conference today, Azar, Birx, Fauchi and Trump kicked ass.

Is it about the possibility of losing the Senate? NC’s Burr ( gotta love his rebuttal - his sales came BEFORE the market decline began- YGBSM ?!?) and GA’s Loefflers stupid inside trades? Loeffler the Trophy Wife Senator‘s hubby is chairman of the NYSE BUT they didn’t discuss her secure briefing? YGBSM Easy to prove it wasn’t her 3 Blind Mice doing it.
20 year$ her senior but a hand$OME dude

NEW MOON MONDAY

[VictorMasonIsRight]

People suddenly worried about 2.5 million new AUTHORIZED shares?
“don’t worry about dilution, the 2.5 million additional AUTHORIZED shares will probably be ISSUED in a 2.5 million share secondary offering at $75 in 4 months OUTSTANDING!!”

Are you not game for the hunt for the white whale Starbuck ? My fate is sealed

[VictorMasonIsRight]

Correction: Monday the 23rd of April

Moby Dick was predicted to arrive at Bikini on the -new moon- in April, this year that’s Monday the 23rd, if this was an omen then that’s the day RLMD blows

[VictorMasonIsRight]

strange coincidence? sent this text to the Bull of Durham my 40 year chartist buddy after watching Moby Dick for the umpteenth time ( it’s a genetic thing)

“Ahab was a technical chartist, Relmada blows April 22, the full moon, at Bikini!”

Since I wrote the previous strange text I got e mail from my brothers friend whose looking after his estate. I asked him to keep a lookout for an 1830 letter from my great great grandfather to a judge in Boston about being shanghaied on a whaler out of New Bedford
He found it!!! It’s an omen!
Thar she blows!!
April 22 full moon is on next Sunday, do we buy on Friday 18th or Monday the 23rd?

[VictorMasonIsRight]

RLMD long pep talk:

https://https://youtu.be/O5Xu5druM94.be/O5Xu5druM94

I’m riding RLMD like Captain Ahab rode Moby Dick

[VictorMasonIsRight]

“Residual price action. Gap filled. Awaiting a new formation. No call at this point.”
—-Mike, The Bull of Durham trusted chartist
“Important pesky gap, good thing it filled, if it doesn’t hold 33 it’s headed lower, 24 next support”
Under $30 you will be paying less than the financiers of Intel and Apple
No word yet on BTD, effect of BTD widely varied for biotech stocks in the past, muted today in these market conditions
According to Dean Koontz 1981 novel Eyes of Darkness the Wuhan400 man made virus will be released in ‘2020’’
Snopes points out it’s not accurate; Wuhan400 has a shorter incubation period and was 100% fatal.
Thanks Snopes!
Later editions call it the Gorky Virus and put the lab in Russia (?)

https://stockcharts.com/h-sc/ui?s=RLMD
$33 is $10 down from 50 day MAV, $10 up from 200 day
Riding it out like Captain Ahab on Moby Dick

[Paulness]

NEWS -- Relmada Therapeutics Appoints CNS Specialist Thomas C. Wessel, M.D., Ph.D., as Executive Vice President, Head of Research and Development

NEW YORK, March 9, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced that Thomas C. Wessel, M.D., Ph.D., has been appointed the Company's Executive Vice President and Head of Research and Development. Dr. Wessel will lead all clinical development and regulatory activities for Relmada.

Dr. Wessel is a board-certified neurologist with extensive drug development experience, including medical lead for three CNS products approved in the United States: Razadyne®, Lunesta® and Ampyra®. Over the last decade, he served as Chief Medical Officer (CMO) for Acorda Therapeutics, Flex Pharma and more recently at Asceneuron. Dr. Wessel gained extensive experience in the development of CNS active isomers as Senior Vice President of Clinical Research at Sepracor. He also worked on several development projects in neurology and psychiatry at Janssen Pharmaceutical (Johnson & Johnson) in Europe and the United States. Dr. Wessel received his M.D. from the Ludwig-Maximilians-University in Munich, Germany, and his Ph.D. in experimental neurobiology at the Max-Planck-Institute for Psychiatry in Martinsried, Germany. Dr. Wessel completed his residency in neurology at New York Hospital and Memorial Sloan-Kettering Cancer Center (Department of Neurology at Weill Cornell University Hospital) where he remained on the faculty for several years as an Instructor and Assistant Professor before joining the industry.

"Tom's vast CNS drug development expertise will be a significant asset to Relmada as we continue to advance our lead product candidate, REL-1017 (dextromethadone), as an adjunctive treatment in patients with major depression and other potential indications," said Sergio Traversa, Chief Executive Officer of Relmada. "Importantly, he has led the development of three U.S. Food and Drug Administration approved CNS products during his distinguished career. Tom's significant clinical development and regulatory experience, in particular with the development of optical isomers, will be especially critical as we prepare to initiate our pivotal Phase 3 study of REL-1017 as an adjunctive treatment in patients with major depression in the second half of this year. We are excited to add someone with his unique background in CNS to our senior executive management team."

"I am thrilled to join the Relmada team at such a critical time in the Company's corporate evolution," said Dr. Wessel. "Based on the data generated to date, REL-1017 has an extremely compelling product profile and, if approved, could provide an important new treatment option with rapid antidepressant onset for patients who suffer from major depression. I look forward to expanding Relmada's clinical development and regulatory activities and working closely with the academic research community and our team to progress REL-1017 in the clinic towards regulatory approval."

Dr. Ottavio Vitolo, who previously served as Relmada's Chief Medical Officer and Head of Research and Development, has left the company to pursue other opportunities. "Relmada is grateful for Dr. Vitolo's contributions to the Company and wishes him the best of luck in his future endeavors," said Sergio Traversa, CEO of Relmada.

About dextromethadone (REL 1017)

Relmada is currently developing dextromethadone as a rapidly acting oral agent for the treatment of depression. Working as an NMDA receptor antagonist and on the same binding site as ketamine but having shown no ketamine psychotomimetics side effects, dextromethadone is fundamentally differentiated from all currently FDA-approved antidepressants, as well as all atypical antipsychotics used adjunctively. In April 2017, the FDA granted Fast Track designation for dextromethadone for the adjunctive treatment of major depressive disorder.

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a clinical-stage, publicly traded biotechnology company developing novel medicines to address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. Relmada's lead program, dextromethadone (REL-1017), is an N-methyl-D-aspartate (NMDA) receptor antagonist in development for the treatment of depression. NMDA receptor antagonists may have utility in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.

Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to" and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.

Investor Contact:

Tim McCarthy
LifeSci Advisors
212-915-2564
mailto://[e-mail]

View original content to download multimedia: http://www.prnewswire.com/news-releases/relmada-therapeutics-appoints-cns-specialist-thomas-c-wessel-md-phd-as-executive-vice-president-head-of-research-and-development-301019680.html

SOURCE Relmada Therapeutics, Inc.

[Paulness]

NEWS -- Relmada Therapeutics to Present at 9th Annual SVB Leerink Global Healthcare Conference

Company Presentation on Thursday, February 27, 2020 at 11:00 AM Eastern Time

NEW YORK, Feb. 25, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced that Sergio Traversa, Chief Executive Officer of Relmada, will present a corporate overview at the 9th Annual SVB Leerink Global Healthcare Conference, taking place February 26-27, 2020, in New York City.

Details of Relmada's presentation are as follows:

Presentation Details:

• Date: Thursday, February 27, 2020
• Time: 11:00 AM Eastern Time
• Webcast: http://wsw.com/webcast/svbleerink34/rlmd/

Please register at least 10 minutes prior to the start of the presentation to ensure timely access. The webcast and presentation will also be archived on the website for 90 days after the conference.

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a clinical-stage, publicly traded biotechnology company developing novel medicines to address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. Relmada's lead program, dextromethadone (REL-1017), is an N-methyl-D-aspartate (NMDA) receptor antagonist in development for the treatment of depression. NMDA receptor antagonists may have utility in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.

Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to" and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all of the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be considered to be a complete list.

Investor Contact:

Brian Ritchie
LifeSci Advisors
212-915-2578
mailto://[e-mail]

View original content to download multimedia: http://www.prnewswire.com/news-releases/relmada-therapeutics-to-present-at-9th-annual-svb-leerink-global-healthcare-conference-301010802.html

SOURCE Relmada Therapeutics, Inc.

[VictorMasonIsRight]

Guggenheim hosting RLMD road show DALLAS tomorrow
Boston today,

[VictorMasonIsRight]

@Relmada Therapeutics: A Promising Depression Focused Player For 2020
Feb. 17, 2020 10:08 AM ETRelmada Therapeutics, Inc. (RLMD)AXSM, VTGN2 Comments
Summary

Relmada Therapeutics' lead asset, REL-1017 can be a game-changer in depression indication.
The company has sufficient funds to sustain its operations.
Investors should consider risks such as business concentration risk, R&D failure risk, and commercial uptake uncertainties.

Today, we will study why Relmada Therapeutics (NASDAQ:RLMD) is an attractive clinical-stage biopharmaceutical pick in 2020.”
REL-1017 can offer a more effective yet safer treatment option for TRD patients
In 2017, there were 17.3 million MDD (major depressive disorder) patients in the U.S. Of these, 10% - 30% suffer from TRD (treatment-resistant depression). NMDA antagonists are fast emerging as a potent class of drugs in the depression indication. REL-1017 can prove to be equal or even superior to the much-touted Ketamine with a stronger safety profile as an antidepressant for TRD patients.

....Like Ketamine, D-methadone seems to possess NMDA antagonist properties which have an anti-depressant effect. This was seen in three animal models of depression. The drug's Phase 1 trial also demonstrated a favourable safety and tolerability profile of the drug. D-methadone has not demonstrated adverse events associated with traditional opioid or ketamine at the expected therapeutic doses. D-methadone is an isomer of racemic methadone.

Normally, racemic methadone is associated with common opioid side effects such as anxiety, nervousness, restlessness, sleep problems (insomnia), nausea, vomiting, constipation, diarrhoea, drowsiness, and others. Published literature shows that left or Levo isomer, l-methadone, is largely is related to opioid activity, while the right or Dextro isomer, d-methadone, has less of that activity.



If approved, Dextromethadone may be a more convenient treatment option in terms of its dosing regimen and route of administration.

REL-1017 has demonstrated robust efficacy and safety in Phase 2 trial
On October 15, Relmada Therapeutics announced positive topline data from Phase 2 REL-1017-202, study evaluating two dosages, 25 mg once a day and 50 mg once a day, of REL-1017 as an adjunctive treatment option for TRD patients....

[VictorMasonIsRight]

RLMD very bullish seeking alpha (!) article
Jeffries analyst Tsai excepts 50-100% gain if RLMD receives Breakthrough status.

REL 1017 worth $1-2 billion if approved for TRD alone ($71-$140/share assuming 14mm shares OI&S)

[Biobonic]

And I'm not selling a share.

Opened UGMA accounts for my three grandchildren, all under 4 years old.

Modest start, 200 shares of RLMD (pre reverse split).

Hope to have $50,000 for them when they graduate HS.

[VictorMasonIsRight]

Tiedmann (1.5%) Parsons (2.5%) and VHCP (5.2%) buy chunks of RLMD, soon there won’t be any stock left

[VictorMasonIsRight]

Just don’t know IF RLMD
has applied for BTD or WHEN they may apply, if they haven’t already.
Company doesn’t leak, they should run the NSC

[Biobonic]

From the FDA web
FDA responds within sixty days of receipt of request. Do we know when Relmada made request?
FDA Web
Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

To determine whether the improvement over available therapy is substantial is a matter of judgment and depends on both the magnitude of the treatment effect, which could include duration of the effect, and the importance of the observed clinical outcome. In general, the preliminary clinical evidence should show a clear advantage over available therapy.

For purposes of Breakthrough Therapy designation, clinically significant endpoint generally refers to an endpoint that measures an effect on irreversible morbidity or mortality (IMM) or on symptoms that represent serious consequences of the disease. A clinically significant endpoint can also refer to findings that suggest an effect on IMM or serious symptoms, including:

An effect on an established surrogate endpoint
An effect on a surrogate endpoint or intermediate clinical endpoint considered reasonably likely to predict a clinical benefit (i.e., the accelerated approval standard) An effect on a pharmacodynamic biomarker(s) that does not meet criteria for an acceptable surrogate endpoint, but strongly suggests the potential for a clinically meaningful effect on the underlying disease A significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity for an oncology agent), with evidence of similar efficacy
A drug that receives Breakthrough Therapy designation is eligible for the following:

All Fast Track designation features Intensive guidance on an efficient drug development program, beginning as early as Phase 1 Organizational commitment involving senior managers
Breakthrough Therapy designation is requested by the drug company. If a sponsor has not requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request if: (1) after reviewing submitted data and information (including preliminary clinical evidence), the Agency thinks the drug development program may meet the criteria for Breakthrough Therapy designation and (2) the remaining drug development program can benefit from the designation.

Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings if any of the features of the designation are to be obtained. Because the primary intent of Breakthrough Therapy designation is to develop evidence needed to support approval as efficiently as possible, FDA does not anticipate that Breakthrough Therapy designation requests will be made after the submission of an original BLA or NDA or a supplement. FDA will respond to Breakthrough Therapy designation requests within sixty days of receipt of the request

[VictorMasonIsRight]

Jeffries wrote Breakthrough Designation could come in ‘1st quarter’
I thought it would be later

[VictorMasonIsRight]

my friend the chartist said it had to back fill to 35-35.5 to resume a strong uptrend, I forgot his warning when it started to run. When will I ever learn to trade?

[VictorMasonIsRight]

Jeffries 41 page buy recommendation today
Now all 3 co managers have published buy reports as expected
After final phase 2 meeting ( first half on 2020) w FDA REL 1017 may get Breakthrough Therapy designation
Watch for large block trades above the offer, whoever it is they haven’t filed a 13D yet
Chart looks like 55-61 short term

[VictorMasonIsRight]

another 100,000 share uptick block ....hmmm

[VictorMasonIsRight]

RLMD 50 day moving average failed to close above 200 day moving average, might take a breather, could resume if FDA grants REL 1017 a ‘breakthrough therapy’, already on Fast Track.

https://stockcharts.com/h-sc/ui?s=RLMD

Not going to sell, ‘expect the unexpected’ -Roald Dahl?
Chartist friend Mike who spotted the strong buy signal at $1.80 (7.20) says it could trade down to support of 351/2 but he's not selling either.
Stronger than expected opening, if there's anything to technical analysis.


?http://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy?

[VictorMasonIsRight]

only reason I wake up at 8:30 is to watch RLMD, today I remembered my sister who got a cross burned in her yard for refunding MLK for a Delta flight he missed, his excuse was pretty good:
“I was in Bull Conner’s jail”

[Biobonic]

Prefer the larger SP of course.

That may be the JNJ low ball offer.

Did they hire Maged Shanouda as CFO just to sell cheap to JNJ?

[VictorMasonIsRight]

Hearing vague rumors about JNJ
I’ve always thought JNJ would buy RLMD, if they paid $100 share it would only be half of what they spent developing Sprovato. Ketamine addiction a big problem in Canada. Just watched a documentary about it.

It makes sense but I hope it doesn’t happen, RLMD will hit 100 on its own this year IMHO, 300-500 once approved

[VictorMasonIsRight]

This chart pattern could improve if it closes above 39.5
Last hour always seems to be the critical time, late lunch? Forgot to enter order?

[VictorMasonIsRight]

This chart pattern is known as the

https://stockcharts.com/h-sc/ui?s=RLMD

‘Leap Out Froggy If You Feel Fit!” Pattern
No, really

[VictorMasonIsRight]

No big pop but that 100,000 share block the other day was an indicator, but it helps
SILICON VALLEY BANK LEERINK only has a $50 short term target but agrees with other revenue projections and profitability estimates, if I’m reading it right 800mm in peak sales with 70% gross margins....huge

[Biobonic]

And you recently added to your share count.

Nice move.

[VictorMasonIsRight]

Relmada Therapeutics (NASDAQ:RLMD) initiated with Outperform rating at SVB Leerink.

[Paulness]

NEWS -- Relmada Therapeutics Strengthens Financial Operations with Addition of Maged Shenouda as Chief Financial Officer

NEW YORK, Jan. 10, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced that Maged Shenouda has been appointed the Company's new Chief Financial Officer (CFO). Mr. Shenouda, who has nearly 30 years of biotechnology and equity research experience, has also stepped down from the Company's Board of Directors in order to join the executive management team. Relmada's current CFO, Charles Ence, will assume a new role in the expanded financial team as the Company's Chief Accounting and Compliance Officer.

"We are thrilled that Maged has agreed to join Relmada's senior executive management team as Chief Financial Officer," said Sergio Traversa, Chief Executive Officer of Relmada. "He is an accomplished financial executive in the biotechnology industry, in addition to his significant industry-related experience as an equity research analyst on Wall Street. Maged's substantial financial expertise and deep understanding of the drug development landscape will be critical to Relmada as we continue to develop our lead product candidate, REL-1017 (dextromethadone), as an adjunctive treatment in patients with major depression. We are also extremely pleased that Chuck Ence will continue with Relmada in the key role of Chief Accounting and Compliance Officer in an expanded financial team. With Maged and Chuck together, we believe that we have extremely solid financial operations in place."

"Having served as a Director on Relmada's Board since 2015, I am truly excited by the significant opportunities ahead of the Company, and its potential to help patients with depression and potentially other CNS disorders," said Mr. Shenouda. "I look forward to joining Relmada's operations as Chief Financial Officer and working with an outstanding team as we execute on our corporate development strategy."

"I am excited