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BWVI NEWS: Psycheceutical Bioscience Inc BWVI:OTC Pink - Current Information
Psycheceutical to Conduct the First Ever Phase I and II Clinical Trials of a Novel Ketamine Topical Cream to Treat PTSD
GlobeNewswire
11:30 AM ET
Psycheceutical to Conduct the First Ever Phase I and II Clinical Trials of a Novel Ketamine Topical Cream to Treat PTSDGlobeNewswireFebruary 15, 2023Psycheceutical â??â??enters into agreement with iNGENÅ« to conduct â??human â??clinical trials of NeuroDirect(TM) ketamine topical â??in AustraliaPhase I trial will study 20 people to test the safety, tolerability, and pharmacokinetics of a single dose of NeuroDirect(TM) ketaminePhase II trial will study 115 participants with PTSD and look at the effectiveness of NeuroDirect(TM) ketamine on improving their symptomsMIAMI, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Psycheceutical Bioscience, Inc. (OTCPK: BWVI) ("Psycheceutical" or the "Company"), a bioscience company dedicated to developing cutting-edge technologies for the next generation of mental health treatments, today announced it has entered into an exclusive agreement with iNGENÅ« Pty Ltd. ("iNGENÅ«"), an Australian-based Contract Research Organization (CR O), to design and conduct two clinical trials to evaluate Psycheceutical's patented NeuroDirect(TM) ketamine topical delivery system.
Psycheceuticalâ??â?? â??is planning to conduct the clinical trials in â??â??Australia. The first in-human, Phase I clinical trial with iNGENÅ« is studying 20 people, each dosed with a single application of NeuroDirect(TM) ketamine. This trial is designed to test the "Safety, Tolerability, and Pharmacokinetics of NeuroDirect Ketamine in Healthy Adult Volunteers."
"We're thrilled to have partnered with iNGENÅ« as we move our proprietary delivery technology into human clin ical trials. iNGENÅ« is an industry-leading, full-service CRO providing end-to-end services for companies like ours developing psychedelic drugs. Together, we're committed to discovering new psychedelic therapies for mental health disorders and central nervous system diseases," said Psycheceutical CEO Chad Harman. "We're eager to engage in this next phase of the development of â??â??â??â??our NeuroDirect(TM) delivery system, which we're designing to solve the issues with side effects that most psychedelic drug development companies face, while at the same time developing lifesaving mental health treatments.â??â??"
â??â??â??The subsequent Phase II clinical trial, also with iNGENÅ«, is targeted to involve 115 participants with PTSD and to analyze the effectiveness of NeuroDirect(TM) ket amine on improving their symptoms. This trial has been designed to be considered for "pivotal clinical trial" recognition by the FDA, which would then allow the Company to proceed directly to a Phase III clinical trial rather than an additional Phase IIb clinical trial, thereby saving the Company significant cost and time.
"Our team is excited to partner with Psycheceutial for their clinical development needs, and we look forward to working together to design and conduct trials with our partners here in Australia," said Dr. Sud Agarwal, CEO of iNGENÅ«. "We're impressed with Psycheceutical's development of psychedelic delivery technologies which potentially offer safer and more effective dosing for patients."
By conducting its clinical trials in Australia, Psycheceutical can take advantage of the Australian federal government's Research & Development Tax Incentive Program, which will provide rebates to the Company of up to 43.5 percent on eligible expenditures for research and development conducted in Australia. "This saves us a considerable amount of capital for the research and development of other novel compounds in our drug pipeline," said Chad Harman, Psycheceutical CEO.
NeuroDirect(TM) for Non-Systemic DeliveryPsycheceutical's NeuroDirect(TM) non-systemic delivery technology is designed to deliver neuro-active compounds directly into the nerve tissue via topical application at the back of the neck. This delivery system is intended to enable immediate and sustained delivery, safe dosage control, and consistent results, while avoiding the systemic side effects of psychedelic compounds such as hallucinations, nausea, and dizziness. NeuroDirect(TM) is designed to be administered at home instead of a clinical setting, greatly lowering the cost of care for both insurance companies and patients, increasing access to these life-saving treatments for anyone suffering from mental health disorders or central nervous system diseases.
About Psycheceutical Bioscience, Inc. Psycheceutical Bioscience, Inc. is developing cutting-edge technologies to advance the safe and effective delivery of psychedelic pharmaceutical medicines. Powered by a team of FDA drug development veterans, biotechnology experts, and the top minds in the psychedelic industry, Psycheceutical is on a mission to commercialize its precision dosing technologies to provide affordable, life-saving treatments to anyone suffering from mental health disorders or central nervous system diseases. Learn more at Psycheceutical.com.
About iNGENÅ«iNGENÅ« is a globally-focused Contract Research Organization (CRO) working exclusively in the cannabinoid and psychedelic space. The company is a full-service CRO performing clinical trials for US, Canadian, and European sponsors in Australia. iNGENÅ« helps companies access the advantages of conducting clinical trials in Australia, including the ability to perform FDA registration clinical trials prior to opening an IND, access to the lucrative 43.5% research and development rebate from th e Australian government on all research expenses, and rapid start-up of clinical trials in under 12 weeks.
BWVI NEWS:Psycheceutical Bioscience Inc BWVI:OTC Pink - Current Information
Psycheceutical Announces Completion of Pre-IND Meeting with FDA for Topical Ketamine Drug to Treat PTSD
GlobeNewswire
10:20 AM ET
Psycheceutical Announces Completion of Pre-IND Meeting with FDA for Topical Ketamine Drug to Treat PTSDCompany intends to pursue 505(b)(2) regulatory pathway for novel topical formulation of ketamine for the treatment of PTSDGlobeNewswireFebruary 02, 2023MIAMI, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Psycheceutical Bioscience, Inc. (OTCPK: BWVI) ("Psycheceutical" or the "Company"), a bioscience company dedicated to developing cutting-edge brain delivery technologies for the next generation of mental health treatments, is pleased to announce it has completed its pre-Investigational New Drug ("IND") meeting with the U.S. Food and Drug Administration (FDA) and received positive feedback regarding the Company's development plans for a novel NeuroDirect(TM) topical formulation of ketamine, intended for treating post-traumatic stress disorder (PTSD).
The FDA has given guidance to Psycheceutical regarding its development plans for preclinical studies required for an IND submission and the design of related Phase I and II clinical studies. In 2023, Psycheceutical remains focused on completing the remaining IND-enabling studies that will support the IND submission and transition into Phase I and Phase II clinical studies.
"We are undergoing a mental health epidemic, with millions suffering from conditions like PTSD with no current therapeutics on the market to help. We believe that NeuroDirect(TM) ketamine has the potential to be a life-altering treatment option that will provide profound benefits and relief to patients suffering from PTSD," said Chad Harman, CEO of Psycheceutical. "We thank the FDA for the constructive guidance during our pre-IND meeting. The constructive feedback and direction will allow us to be efficient and systematic towards safely transitioning our novel topical treatment from preclinical studies into a full clinical evaluation."
In written responses to the questions provided by Psycheceutical, the FDA provided guidance on inquiries related to manufacturing, safety/toxicology, pre-clinical efficacy studies, clinical trial design, and the rationale necessary to support subsequent human clinical trials. This feedback supports Psycheceutical with greater clarity on the current requirements needed to file an acceptable IND to initiate Phase I and II clinical trials of NeuroDirect(TM) ketamine.Based upon the historical clinical data for ketamine and the C ompany's preclinical testing planned for NeuroDirect(TM) ketamine in 2023, the Company anticipates filing an IND by the end of 2023. In addition, Psycheceutical intends to pursue accelerated approval through one of the FDA's expedited drug approval programs, such as Breakthrough Therapy, pending the development of preliminary clinical evidence to support such designation.
NeuroDirect(TM) for Non-Systemic DeliveryPsycheceutical's patented NeuroDirect(TM) non-systemic delivery technology is designed to deliver neuro-active compounds directly into the nerve tissue via topical application at the back of the neck. This delivery system is intended to enable immediate and sustained delivery, safe dosage control, and consistent results, while avoiding the systemic side effects of psychedelic compounds suc h as hallucinations, nausea, vomiting, and toxicity. NeuroDirect(TM) is designed to be administered through telehealth or at home instead of a clinical setting, greatly lowering the cost of care for each patient, ensuring that these life-saving treatments are cheap and available to anyone suffering from mental health disorders or central nervous system diseases.
About Psycheceutical Bioscience, Inc. Psycheceutical Bioscience, Inc. is developing cutting-edge technologies to advance the safe and effective delivery of psychedelic pharmaceutical medicines. Powered by a team of FDA drug development veterans, biotechnology experts, and top minds in the psychedelic space, Psycheceutical is on a mission to commercialize its precision dosing technologies to provide affordable, life-saving treatments to any one suffering from mental health disorders or central nervous system diseases. Learn more at Psycheceutical.com.
Forward-Looking Statements:Certain statements in this news release related to the Company constitute "forward-looking information" within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These uncertainties include, but are not limited to, (i) general market growth for and acceptance of psychedelic-inspired medicines, (ii) capital and credit availab ility and market volatility, (iii) general economic conditions, (iv) governmental approvals and compliance with regulations, (v) product research and development and clinical trial risks, (vi) incorrect underlying assumptions, and (vii) our future business development, results of operations, and financial condition. These statements generally can be identified using forward-looking words such as "will," "may," "should," "could," "intend," "estimate," "plan," "anticipate," "expect," "believe," "potential" or "continue," or the negative thereof or similar variations. All information provided in this press release is as of the date of this press release, and we undertake no duty to update such information, except as required under applicable law.
Contact:
Kaia Roman, VP, Strategy & Communications kaia.roman@psycheceutical.com
BWVI NEWS: Psycheceutical Bioscience Inc BWVI:OTC Pink - Current Information
Psycheceutical Bioscience Provisional Patent Application for Novel Ketamine Topical for the Treatment of PTSD
GlobeNewswire
12:15 PM ET
Psycheceutical Bioscience Provisional Patent Application for Novel Ketamine Topical for the Treatment of PTSDTopical ketamine formulations could improve the methods of treating post-traumatic stress disorder (PTSD)GlobeNewswireJanuary 26, 2023MIAMI, Jan. 26, 2023 (GLOBE NEWSWIRE) -- Psycheceutical Bioscience, Inc ("Psycheceutical" or the "Company") (OTC: BWVI), a bioscience company dedicated to developing cutting-edge treatments for mental health, has filed a provisional patent application with the United States Patent and Trademark Office (USPTO) for the first ketamine topical intended for treating post-traumatic stress disorder (PTSD).
The provisional patent application describes ketamine formulations for topical administration and related methods of treating PTSD, utilizi ng NeuroDirect(TM) non-systemic drug delivery technology. This delivery system is designed to topically distribute neuro-active compounds to the back of the neck for immediate action on a dense population of brain nerve endings. These novel ketamine formulations, and methods of treatment, are being developed to reduce the side effects caused by prior formulations, such as hallucinations, nausea, lethargy, and toxicity, but more importantly to also reduce pain and symptoms of PTSD.
"PTSD can be a serious mental health disorder, with no known effective therapeutic solutions currently available. Millions of people suffer each year," said Chad Harman, Chief Executive Officer of Psycheceutical. "But there is new hope. This patent application supports Psycheceutical's ongoing drug development plans for its revolutionary NeuroDirect(TM) topical delivery system that we believe has the potential to provide new solutions and treatments for PTSD and other mental health conditions."
PTSD is a common mental health condition affecting hundreds of millions of people worldwide, with symptoms ranging from mild to severe. PTSD is commonly interconnected with other mental health conditions, such as anxiety, depression, and substance abuse disorder. People who suffer from PTSD also have a higher risk of suicide.
"Psycheceutical is driven to provide new hope for this debilitating disorder by employing cutting-edge technologi es for the patients who need it most," said Dr. Julian Bailes, Chief Medical Officer of Psycheceutical. "We look forward to improving current mental health treatments while progressing the capabilities of the psychedelic pharmaceutical category."
NeuroDirect(TM) for Non-Systemic DeliveryPsycheceutical's NeuroDirect(TM) non-systemic delivery technology is protected by several patents and pending applications, and is designed to deliver neuro-active compounds directly into the nerve tissue via topical application at the back of the neck. This delivery system is intended to enable immediate and sustained delivery, safe dosage control, and consistent results, while avoiding the systemic side effects of psychedelic compounds such as hallucinations, nausea and vomiting. NeuroDirect(TM) is designed to be administered through telehealth or at home instead of a clinical setting, greatly lowering the cost of care for each patient, ensuring that these life-saving treatments are cheap and available to anyone suffering from mental health disorders or central nervous system diseases.
About Psycheceutical Bioscience, Inc. Psycheceutical Bioscience, Inc. is seeking to develop cutting-edge delivery technologies to support and advance the safe and effective delivery of psychedelic pharmaceutical medicines. Powered by a team of FDA drug development veterans, biotechnology experts, and the top minds in the psychedelic space, Psycheceutical is on a mission to develop, improve and commercialize its precision dosing technologies to provide affordable, life-saving treatments to anyone suffering from mental health disorders or central nervous system diseases. Learn more at Psycheceutical.com.
Forward-Looking Statements:Certain statements in this news release related to the Company constitute "forward-looking information" within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These uncertainties include, but are not limited to, (i) general market growth for and acceptance of psychedelic-inspired medicines, (ii) capital and credit availability and market volatility, (ii i) general economic conditions, (iv) governmental approvals and compliance with regulations, (v) product research and development and clinical trial risks, (vi) incorrect underlying assumptions, and (vii) our future business development, results of operations, and financial condition. These statements generally can be identified using forward-looking words such as "will," "may," "should," "could," "intend," "estimate," "plan," "anticipate," "expect," "believe," "potential" or "continue," or the negative thereof or similar variations. All information provided in this press release is as of the date of this press release, and we undertake no duty to update such information, except as required under applicable law.
Contact:
Kaia Roman, VP, Strategy & Communications kaia.roman@psycheceutical.com
Knowing what we know now, I think its safe to say that "Timing is Everything!" When it comes to charts and chart set ups, Momentum Plays and Investor Awareness Campaigns, you have to know when to buy and when to sell. VOLUME is always key. A stock without liquidity isn't worth trading unless you like being a bagholder. Some of the stocks we enter may currently lack liquidity, but based on our DD, we expect there to be liquidity coming soon. We will also provide email alerts for stocks that may be profiled at this board or chart patterns that may be ready to break out.
During the evenings and some mornings I will work on posting here.
Board Rules:
1) Spam of any kind will not be tolerated
2) There will be times when posters are not in agreement, that is healthy, but please no personal attacks.
3) No specific price preference for the board
4) Volume is the blood in a stock's veins, so I typically prefer stocks with historical volume, otherwise there is little liquidity for selling the stock if need be.
5) Posting charts and annotations if you have a service that provides it are highly welcome since this provides support for your buy/sell/hold signal.
6) As always, do your due diligence, and remember that there is high risk in these types of stocks. Never trade with money that you cannot afford to lose.
7) If the post is Off Topic, please post with OT prefacing the post.
MUST READ FOR ANYONE NEW TO THE OTC / PENNY STOCKS:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=30835203
Folks, please becareful which plays you jump into. I've been at this a few years and there are plays that go bad for whatever reason and it happens to the best Investment Awareness professionals out there. BUT there are also folks who PRETEND to be your friends on message boards and they just want YOUR money and they will say ANYTHING to get it. Then I hear about how they brag about it and it sickens me. I bought PPBL BEFORE the big announcement and couldn't even make a lousy 10% on it before the front loading pig(s) were tripping over himself / themselves to dump. They can claim they'll post a screen shot which means JACK. I trade out of 3 different accounts. You won't see me posting on those message boards where I KNOW there is a high percentage that most who buy the stock will end up Bagholders. A GOOD Promoter / Investor Awareness Professional doesn't front load heavily and dump all over everyone after the play is announced. He / She does their HOMEWORK to make sure the company is going to create shareholder value and NOT DILUTE all over folks coming into the stock.
No doubt we've all been in a stock that we jumped into from reading a message board only to regret the decision a short time later before exiting for a loss. In my case it's happened on many occasions although less frequently now. (tuition has been a bit expensive at times) I don't know all the players behind various "plays" but I do know about how the game is played. Some "Investor awareness Professionals" are much more trust worthy than others. Some who are more trust worthy have plays that don't work out because they were mislead by the company or they left some facet of DD unchecked. The one thing you can do in just about every case is look at the chart to see what happens after a play is announced. What happens to the Accum / Dist line and the OBV tells the story in many cases. If you see a sharp decrease in both you are likely seeing retail front loaders dumping and dilution and or shorting (shorting does happen but all to often it's the company selling, I've seen it over and over and over again even when the company and everyone else is denying it). those are the plays I exit and I'm not interested in coming back in on a bounce either. I don't look back in most cases.
So what's the answer? FORCE yourself to watch some plays from the sidelines and learn how the game works and get a feel who you can trust and who doesn't deserve your trust. I've learned not to believe everything in a PR and especially on a message board. I could show you posts of folks who swore they didn't front load or know about a play yet I know for a fact that they did. Some folks I know post about how much they are buying when I know they are selling. I'm not here to rat out anyone. I'm just explaining to some degree what goes on. Folks have to learn who they can trust and the biggest criteria is past performance. Not every one of their plays may have been a 100%+ gainer and not everyone is going to make money on every play no matter how much it goes up. I don't mind getting in plays where promoters have some shares to sell or the company is going to raise some money so long as I believe the selling will be done responsibly and shareholders are getting value for the shares coming into the market.
One last thing I think everyone knows already and again, this is for new folks. Penny stocks & ESPECIALLY NON REPORTING PINKS are not LONG TERM investments and probably only good for a week to a couple months max in MOST cases. (RTGV is my one exception) You'll preserve MUCH capital showing discretion which promoters / Investor Awareness Professionals are trustworthy and which are not. GLTUA!
OUTSTANDING DAILY Market Analysis. I watch this EVERY evening. Takes 10 minutes and a MUST listen for serious investors.
http://thechartpatterntrader.com/
Some relevent info:
1) For SEC filings I use "http://www.pinksheets.com"
2) For charts, I use "http://www.stockcharts.com" (with membership to provide additional features and annotations)
3) To post a chart, right click on the chart and choose Properties, then copy the portion following the "http://",
then to post use '[chart'] <paste in chart link previously copied.> followed by '[/chart'] (the quotes before and after are not to be included when posting but are required so that Ihub doesnt think Im trying to post a chart)
4) I use www.alphatrade.com for Level II including pink sheet Level II
5) I use Microcaptrader, ie. www.microcaptrade.com, for real time news, watch list, scanning, and an overall realtime portal of stocks and their movements throughout the day.
6) GO to http://www.investorwords.com/ for a great listing of stock terms
7) For more info on chart formations, see http://www.chartpatterns.com
8) For info on shell stocks: http://www.ShellStockReview.Com
9) For historical charts on pink sheet stocks including volume for the day, low, high, open and close prices, go to http://www.stockhouse.com
10) For symbol changes: http://www.investorshub.com/boards/board.asp?board_id=1564
11) I recommend subscribing to www.otcbb.com for "The Daily List
" which contains a listing of symbol changes, and share structure changes, such as reverse and forward splits.
12) Remember also, to sell into strength, and buy into weakness. When possible, try not to sell at the bid, when a stock is strong, you can usually at least get filled somewhere between the bid/ask, selling at the bid will often hurt the stock, since the market makers make take the bid down further afterwards.
13) I recommend http://www.acmechart.com which is a service that delivers signals for when certain BBs/pinks cross certain technical points which indicate that a change in direction. Has made me some nice profits, at times when I was not noticing the trend building, great tool imo.
14) A free video is available (example) for education purposes to help with understanding the skills required for trading:
http://www.stockwire.com/index.php?option=com_content&task=view&id=113&Itemid=68
15) Also available, are videos on youtube for technical analysis:
http://investorshub.advfn.com/boards/read_msg.asp?message_id=25550229
16) Here is a link to the OTCBB short interest site. Slightly more than halfway down the page where it says "View by Security", you can enter the Ticker Symbol for whatever OTCBB stock you want.
http://www.otcbb.com/asp/OTCE_Short_Interest.asp
17)Short interest for AMEX stocks.
http://www.amex.com/amextrader/tradingData/amexShortInt/AmexShortInterest.jsp
18) Failure To Delivers (FTD)
http://stocksweek.com/fails.php?report=cnsfails200907b.txt&symbol=tteg&submit=submit
19) ShortSqueeze.com
http://shortsqueeze.com/
For info on stockcharts.com, see the Stockcharts board on the Hub:
http://www.investorshub.com/boards/board.asp?board_id=1277
The ULTIMATE big board charting service around. http://www.stockfetcher.com allows you to scan for stocks, create filters, scan for indicator breakouts and scan for CHART PATTERNS. This is the ultimate tool for all big board players and a must have imo to help track technical analysys.
Valuation and Investing - the basics
http://www.youtube.com/user/khanacademy#p/c/370CD04C45C6BB81
Finance
http://www.youtube.com/user/khanacademy#grid/user/9ECA8AEB409B3E4F
Collateralized Debt Obligation (CDO)
http://www.youtube.com/user/khanacademy#p/c/9ECA8AEB409B3E4F/28/XjoJ9UF2hqg
Ascending Triangle is When a chart makes higher lows but not higher highs, entrance on the bottom trendline or when the price breaks above the previous flatline of highs. Sell when the stock makes a lower low.
Descending Triangle is When a stock holds its lows but makes lower highs. Buy at support bottom trendline or makes its first higher high and sell when it loses support or makes a lower low.
Symetrical Triangle is When a stock makes lower highs AND higher lows, buy at the bottom trendline or when the stock makes its first breakout with a higher high and sell when it makes a lower low or profits are made.
DISCLAIMER:
Opinions expressed on this board are only people's opinions. I, nor any moderator or assistant of this board is a licensed broker. Trading strategies discussed on this board are often high risk and not suitable everyone.
No one is responsible for your gains or losses in the market except YOU. If you follow stock strategies, charts and or buy and sells signals discussed on this board you may LOSE ALL YOUR MONEY. Please weigh the strategies discussed here carefully against what you are willing to risk.
Please do your own due diligence before buying or selling ANY SECURITY in the open market, there are no guarantees.
Make Sure You Sign Up For All Of Our Email Alerts!!: http://investorshub.advfn.com/boards/chairmail_sub.asp?board_id=12820
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