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Lets go BWVI, Psycheceutical.com setting up nicely. Company talking with the FDA, going in to trials. Future looks great!
Hear from Chief Visionary Officer @ZappyZapolin on @thedalesreport's #TradetoBlack Podcast and hear more about his insights into the burgeoning #psychedelicmedicine space.
— Psycheceutical (@psycheceutical) February 24, 2023
For the full episode: https://t.co/D2JITcY7dg pic.twitter.com/W7q5RCqNdv
Invest in the growing psychedelics industry and join Strategic Advisor @HarringtonKevin as he moderates the 'Evolution of The Legal Psychedelics Industry' panel & offers his Shark Tank expertise at @kahnerglobal's Cannabis & Psychedelics Investment Summit: https://t.co/TkA7SG5Zek pic.twitter.com/eaphbS1nnu
— Psycheceutical (@psycheceutical) February 23, 2023
Come on finra, one job get it done!
$SSFT up 329%, just saying! Let see how last hour goes! Lotta shorts to cover , if you look at this, plz do some level dd to know what happening
Who knows! I dont care shorty gonna overcome all their volume anyway, great way to start the long weekend , with large wads of cash made!!!
Make that 300%! Last hour gonna be nutz!
$SSFT up 300% on day and rising! Shorty gotta cover!
265% and rising, cover it shortie! Probably didnt go daily yet allowing one more day of trading or so to let all the shorts cover! There were a lot of them!
$SSFT up 265% now
$SSFT up 265% now
$SSFT up 229% on the day so far just saying! Shorts, gotta cover!
$SSFT up 229% on the day so far just saying! Shorts, gotta cover!
All those naked shorts that have been fing with us got a cover before it goes to the daily! The stock has been a great money maker over the years and it’s gonna end with the best yet!
Yeah, always something, it was just two lines, but they were OK with it before they’re always changing their mind. It’s more important as we continue the trend of increasing revenues quarter after quarter
We are looking great for the future. Already working with FDA on clinical trial design
Yeah, me too making good money up 150% on the day plus with the runs that we had before. I’ve made pretty good bank over the years on the stock and the end game is gonna be awesome.
Doubled gains plus from low yesterday, nice!
Recovering nicely! Watching the daily, trading going to be over soon. But i like the set up. Lots of reasons quiet ill bet. This best path
Forward for buyout. Those cheaps yesterday were nice!
Got Psycheceuticals? $BWVI huge news! Leading the path to major medicine for the masses!
Psycheceutical Announces Completion of Pre-IND Meeting with FDA for Topical Ketamine Drug to Treat PTSD
Press Release | 02/02/2023
MIAMI, 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™ 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™ 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™ ketamine.
Based upon the historical clinical data for ketamine and the Company's preclinical testing planned for NeuroDirect™ 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™ for Non-Systemic Delivery
Psycheceutical’s patented NeuroDirect™ 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, vomiting, and toxicity. NeuroDirect™ 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 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, (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
Got Psycheceuticals? $BWVI huge news! Leading the path to major medicine for the masses!
Psycheceutical Announces Completion of Pre-IND Meeting with FDA for Topical Ketamine Drug to Treat PTSD
Press Release | 02/02/2023
MIAMI, 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™ 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™ 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™ ketamine.
Based upon the historical clinical data for ketamine and the Company's preclinical testing planned for NeuroDirect™ 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™ for Non-Systemic Delivery
Psycheceutical’s patented NeuroDirect™ 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, vomiting, and toxicity. NeuroDirect™ 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 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, (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
.@psycheceutical in partnership with iNGENū has announced two clinical trials to evaluate Psycheceutical’s patented NeuroDirect ketamine topical delivery system for the treatment of #posttraumaticstressdisorder. https://t.co/hqS6XuK8e2 #PTSD pic.twitter.com/9NExPrtKRr
— Genetic Engineering & Biotechnology News (@GENbio) February 16, 2023
This is going to change the world. Peace. Zappy https://t.co/c6PVVR4Q5Z
— Zappy Zapolin (@ZappyZapolin) February 15, 2023
6 Qs in a row great growth! Millions in revenues and continuing to climb! Looking great here!
$FUNN
Interesting situation! Buyout or merger coming? You don’t make a
Move like this for nothing and call it in the best interest for shareholders
Amazing News! Leading the charge to test out the platform, FDA involvement for clinical trial design. Ideally this goes through fast as it is an efficacy of platform with ketamine not ketamine itself
Awesome news, the roll out has started, its getting great fast, lets goooo FINRA!
Psycheceutical Announces Completion of Pre-IND Meeting with FDA for Topical Ketamine Drug to Treat PTSD
Press Release | 02/02/2023
MIAMI, 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™ 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™ 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™ ketamine.
Based upon the historical clinical data for ketamine and the Company's preclinical testing planned for NeuroDirect™ 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™ for Non-Systemic Delivery
Psycheceutical’s patented NeuroDirect™ 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, vomiting, and toxicity. NeuroDirect™ 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 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, (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
The important thing is the continued trend Quarter after Quarter of results. This is great and we are turning the corner for sure. One nice thing on the locations only business is it is good for cash flow, distribution requires large cash up front with an unknown recollection period. The locations are much easier for planning and predicting, less juggling needed.
Everything trending well, this isnt just one or two Q now this is multi year and getting stronger
Looking great!
$FUNN
Yes the trend is strong. Quarter after Quarter. As I previously posted
We would survive and then Thrive! Everything is moving in the right direction, we see what happens but i dont expect the fiscal year level to be profitable quite yet but the gains and momentum are amazing. (Maybe ill get surprised but just guessing) It will certainly close the gap by a huge % and be near the mark. Add a location or two and certainly FY24 will be the year of full profits and make the company self sustaining. At that point US banking / investing can get involved for even faster expansion.
Looking great though, awesome trend and it states it is continuing!
$FUNN
Exactly, the trend continues. At the end of the day, the gap is closing to that annual self sustaining profitable level. They gave guidance in Jan we will continue improving and this is proof. Lets add more locations and keep scaling up.
The data being produced in the USA will be used for being able to work with our banking and financial systems.
This is a great milestone period.
$FUNN
NET PROFITABLE! Yes! This is a testament to the STRENGTH of the brand. We CONTINUE TO CRUSH IT! More locations coming to add and keep on until we get to that critical overall annual level of sustained profits. This is an AMAZING accomplishment, coming from the lows of pandemic, to be here STRONGER than ever!
Financials CONTINUE to improve, we have the DATA to show the great trend and it looks to keep going where we want.
LOVE TO SEE THIS
Looking forward to the follow up PR!
GREAT work to the whole S&L team!
$FUNN
With last week's major announcement from Australia, many are wondering how long it will be before other countries, like the United States, follow a similar path toward legalizing psychedelic medicines.
— Psycheceutical (@psycheceutical) February 13, 2023
It could be sooner than you think...
Read via @Time: https://t.co/E7jZ4F6plT pic.twitter.com/KaN2lsXyrL
World round medicine is coming for the people!
In a landmark development for #psychedelicmedicine, the Australian Therapeutic Goods Administration (@TGAgovau) has announced it will soon make it possible for psychiatrists to prescribe psilocybin and MDMA as early as July of this year.
— Psycheceutical (@psycheceutical) February 9, 2023
Read in @Forbes: https://t.co/XyZGFhpgHe" pic.twitter.com/ZiMr1Abmly
“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.” Love they been working with the FDA and creating the regulatory path to bring much needed medicine to the masses!
Its coming, i believe they were timing with finra ticker change to avoid confusion. Finra been slowwww but its gotta happen sooner or later. In the meantime they are starting to let the news flow
Looking good!
Strategic Advisor @HarringtonKevin took the stage Thursday at Cannadelic with Chief Visionary Officer @ZappyZapolin to discuss the #psychedelicmedicine business model and Psycheceutical's mission to bring forward new solutions for #mentalhealth treatment. pic.twitter.com/tfQy4wYBh9
— Psycheceutical (@psycheceutical) February 4, 2023
Continuing the exciting announcements, today we're pleased to share news of the completion of our Pre-IND meeting with @US_FDA with positive feedback for our novel NeuroDirect™ topical formulation of ketamine for treating #PTSD.
— Psycheceutical (@psycheceutical) February 2, 2023
Read the announcement: https://t.co/1sheb0Wa9W pic.twitter.com/ZoRFGJ3alq
Millions in revenues and growing. Three years of solid revenue growth. Locations EBITDA positive and more locations coming.
Looking forward to the next update!
$FUNN
Accumulating while its down here, going to be great!