Pharmather Holdings Ltd. (PHRRF)

[tradernewstip]

$PHRRF The Company aims to submit its responses to the FDA by the end of this week. There can be no assurance the GDUFA goal date will be met. Should the goal date not be met, the FDA would provide a Complete Response Letter to the Company to address the responses, provide additional feedback, if any, and assign an appropriate goal date. The Company is prepared to address potential FDA requests and concerns immediately and will update shareholders as they occur.
https://finance.yahoo.com/news/pharmather-provides-priority-original-abbreviated-120000352.html

[Skiluc]

Way undervalued. Only been saying it years now.

[Impacto]

Adding. Way cheap now!!!!

[WesCrowe]

Was info leaked on fda decesion or just market makers screwing with retail?

[scottyb]

thanjs for the valuable information

[scratchy]

Good way to end the week

[scratchy]

Nice day

[2014shelby]

PHRRF looking good. GLTA

[longtrailer]

Probably run up to FDA decision in April 2024.

PharmaTher Provides Update of its Priority Original Abbreviated New Drug Application for Ketamine
https://finance.yahoo.com/news/pharmather-provides-priority-original-abbreviated-130000660.html

Fabio Chianelli, CEO of PharmaTher, commented: “We believe 2024 will be a transformative year for PharmaTher with the expected FDA approval of ketamine having an assigned goal date for approval on April 29, 2024. In anticipation of a potential FDA approval, we are focusing on the commercial scale-up of ketamine in the U.S. and seeking additional international approvals.”

[scratchy]

Why the volume increase lately?

[2014shelby]

Nice volume recently. GLTa shareholders

[threebabiesbusy]

What???

[willlbone]

Bid 10 cents

[tradernewstip]

$PHRRF 80% strong buy opportunity from @Barchart
https://www.barchart.com/stocks/quotes/PHRRF/opinion

[threebabiesbusy]

Fabio Chianelli, CEO of PharmaTher, commented: “We believe 2024 will be a transformative year for PharmaTher with the expected FDA approval of ketamine having an assigned goal date for approval on April 29, 2024. In anticipation of a potential FDA approval, we are focusing on the commercial scale-up of ketamine in the U.S. and seeking additional international approvals.”

[2014shelby]

https://finance.yahoo.com/news/pharmather-provides-expected-fda-approval-123000873.html

[2014shelby]

PHRRF continuing that nice climb upwards today. GLTA shareholders

[AKATITUS]

Looking good.

[2014shelby]

52 week high again today. GLTA shareholders

[2014shelby]

52 week high today! Nice

[tradernewstip]

$PHRRF Strong buy from technical analysis from tradingview https://www.tradingview.com/symbols/OTC-PHRRF/technicals/

[Inspector Clouseau]

I think we will do well here,it seems like a sure thing that we will be marketing this in early 2024.GLTA

[2014shelby]

https://www.globenewswire.com/news-release/2023/09/27/2750259/0/en/PharmaTher-Announces-FDA-Acceptance-As-a-Priority-Original-Abbreviated-New-Drug-Application-for-KETARX-Ketamine.html

[tradernewstip]

$PHRRF $PHRM The Company’s lead product is KETARX™ (racemic ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, and neurological indications.
@RexWiggins12
https://thenew.money/article/hedge-fund-billionaire-steve-cohen-is-betting-on-psychedelics

[tradernewstip]

$PHRRF News Out! PharmaTher Submits Priority Original Abbreviated New Drug Application for KETARX™ (Ketamine) to the FDA
https://finance.yahoo.com/news/pharmather-submits-priority-original-abbreviated-113000329.html

[tradernewstip]

$PHRRF Update : September 2023 Corporate Presentation https://www.pharmather.com/uploads/1/2/5/8/125844350/deck_-_phrm_-_1020201.pdf
#Ketamine #psychedelics #cepharanthine $PHRM $PHRM.C

[tradernewstip]

$PHRRF
Transdermal Medical Patch Market worth $10.79 Billion by 2028 - Exclusive Report by The Insight Partners
Global transdermal medical patch market is growing at a CAGR of 4% from 2023 to 2028.
@RexWiggins12

https://globenewswire.com/news-release/2023/09/04/2736780/0/en/Transdermal-Medical-Patch-Market-worth-10-79-Billion-by-2028-Exclusive-Report-by-The-Insight-Partners.html

[Nosnibor]

Certainly encouraging.

[2014shelby]

Interesting that PHRRF and RVVTF mentioned in the article below. GLTA

[2014shelby]

From the article below:

“In February 2023, Revive Therapeutics Ltd. entered into a research collaboration agreement with PharmaTher Holdings Ltd. to evaluate the delivery of 3,4-Methylenedioxymethamphetamine ("MDMA") using PharmaTher's novel microneedle patch ("MN-Patch") delivery technology. The MDMA MN-Patch enables flexible drug load capacity and combinations, controlled released delivery, and the ability to present desired pharmacokinetic and safety profiles, overcoming the potential obstacles of oral dosing.”

[2014shelby]

GLTA shareholders

[2014shelby]

https://www.globenewswire.com/news-release/2023/09/04/2736780/0/en/Transdermal-Medical-Patch-Market-worth-10-79-Billion-by-2028-Exclusive-Report-by-The-Insight-Partners.html#:~:text=Transdermal%20Medical%20Patch%20Market%20in,published%20by%20The%20Insight%20Partners.

[tradernewstip]

Nice DD here. - PHRRF https://www.barchart.com/stocks/quotes/PHRRF/cheat-sheet

[threebabiesbusy]

Excellent

[longtrailer]

PharmaTher Initiates Filing of Abbreviated New Drug Application for KETARX™ (racemic ketamine) to the FDA

June 27, 2023 - 7:00 am
Expected FDA approval for KETARX™ (racemic ketamine) via the ANDA pathway in Q1-2024 and commercial launch in Q2-2024

TORONTO, June 27, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, is pleased to announce it has filed a Pre-Submission Facility Correspondence in advance of its Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”) to support expedited review of its priority ANDA. The filing of a Pre-Submission Facility Correspondence will help achieve approval early compared to the standard ANDA approval times. The Company anticipates KETARX™ approval from the FDA as early as Q1-2024 and commercial launch in the U.S. in Q2-2024 followed by the pursuit of international approvals to support the growing global demand for ketamine.

Ketamine is an essential medicine used for anesthesia and analgesia (pain relief) listed on the WHO Essential Medicines List. Ketamine has been on the FDA’s drug shortage list since February 2018. In Canada, ketamine has been classified as a Tier 3 drug shortage since February 2023, and Health Canada has approved ketamine for use as a sedative and painkiller in hospital settings. Outside of the FDA and Health Canada approved indications, ketamine is also being administered in hospitals and clinics to treat various disorders encompassing mental health, neurological and pain. A recently published new peer-reviewed study on the real-world effectiveness of ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation.

PharmaTher’s priority is to commercialize KETARX™ in the U.S. under ketamine’s FDA-approved label through its recently announced partnership with Vitruvias Therapeutics, Inc., a leading U.S. based specialty generic pharmaceutical company. The Company expects to market various dosage forms of KETARX™, such as 10 mg/ml, 50 mg/ml and 100 mg/ml, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) develops and commercializes specialty pharmaceuticals exhibiting growing adoption and permitting novel delivery methods to enhance patient outcomes. The Company’s lead product is KETARX™ (racemic ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, and neurological indications. The Company is commercializing PharmaPatch™ (microneedle patch) with its partners to deliver psychedelics and drugs to treat infectious diseases. Learn more at PharmaTher.com.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: [phone]
Email: [e-mail]
Website: www.pharmather.com

[threebabiesbusy]

News release won’t copy and paste but solid news today

Expected FDA approval for KEYARX(TM) (racemic ketamine) via the a ANDA pathway in Q1, 2024 and commercial launch in queue to 2024

Bout time!

[2014shelby]

Looking good here

[2014shelby]

Looking forward to more updates from PHRRF

[2014shelby]

Nice move up today. GLTA shareholders

[2014shelby]

https://www.pharmather.com/news/pharmather-and-vitruvias-enter-into-collaboration-agreement-for-commercialization-of-ketarxtm-racemic-ketamine-in-the-us

[longtrailer]

PharmaTher Holdings Provides Corporate Update

https://www.bing.com/ck/a?!&&p=1efe6dd56f5e71aeJmltdHM9MTY4NjYxNDQwMCZpZ3VpZD0yMjMzYmY5OS0wZGM4LTZjYTgtMTI4Ny1hZDJmMGM1YjZkN2YmaW5zaWQ9NTE4Ng&ptn=3&hsh=3&fclid=2233bf99-0dc8-6ca8-1287-ad2f0c5b6d7f&psq=PharmaTher+Holdings+Provides+Corporate+Update&u=a1aHR0cHM6Ly93d3cuZ2xvYmVuZXdzd2lyZS5jb20vZW4vbmV3cy1yZWxlYXNlLzIwMjMvMDYvMTIvMjY4NjE1NS8wL2VuL1BoYXJtYVRoZXItSG9sZGluZ3MtUHJvdmlkZXMtQ29ycG9yYXRlLVVwZGF0ZS5odG1s&ntb=1

[threebabiesbusy]

When are we going to move and stay north of .10….?

[longtrailer]

$PHRRF NEW ARTICLE : PharmaTher Holdings Announces Update of Type C Meeting with the FDA for KETARX™ (Ketamine) in Parkinson's Disease

https://www.pharmather.com/news/pharmather-holdings-provides-update-for-ketarxtm-racemic-ketamine-development-programs-and-expected-milestones-for-2023#:~:text=KETARX%E2%84%A2%20Type%20C%20meeting%20granted%20by%20FDA%20for,treatment%20of%20levodopa-induced%20dyskinesia%20in%20Parkinson%E2%80%99s%20disease%20%28%E2%80%9CLID-PD%E2%80%9D%29.

[2014shelby]

PHRRF making some nice moves up. GLTA shareholders

[longtrailer]

PharmaTher Submits FDA Meeting Package to Discuss 505(b)(2) Pathway for New Drug Application of KETARXâ?¢ (Ketamine) On-Body Pump System

[longtrailer]

Proposed KETARX on-body pump kit and application.

https://charts.stocktwits-cdn.com/production/original_510789717.png

(Posted on Stocktwits)

[threebabiesbusy]

GLTA!

[2014shelby]

Agreed. GLTA shareholders

[threebabiesbusy]

Wish I’d bought more in the .05-08 range.

[2014shelby]

Agreed. Looking forward to more updates and good news

GLTA shareholders