PharmAla Launches MDMA Clinical Trial Tool for Researchers
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) has launched a new MDMA Clinical Trial Tool for researchers. This tool provides direct access to Chemistry, Manufacturing and Control (CMC) data and the company's investigator's brochure to qualified researchers. The initiative comes in response to a surge in requests for MDMA research materials following the FDA's decision on Lykos' New Drug Application for MDMA.
The tool, available at pharmala.ca/clinical-trials, aims to streamline the process for researchers applying for trials with MDMA and boost PharmAla's sales pipeline for clinical trials using LaNeo MDMA. Additionally, PharmAla announced the appointment of William Avery, CPA, CA, as the new Chief Financial Officer, effective October 1st, replacing outgoing CFO Carmelo Marelli.
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) ha lanciato un nuovo Strumento per la Sperimentazione Clinica MDMA per i ricercatori. Questo strumento fornisce accesso diretto ai dati su Chimica, Produzione e Controllo (CMC) e alla brochure per gli investigatori dell'azienda a ricercatori qualificati. L'iniziativa è stata presa in risposta a un aumento delle richieste di materiali di ricerca su MDMA dopo la decisione della FDA riguardo alla Nuova Domanda di Farmaco di Lykos per MDMA.
Lo strumento, disponibile su pharmala.ca/clinical-trials, mira a semplificare il processo per i ricercatori che richiedono prove cliniche con MDMA e a potenziare il pipeline di vendite di PharmAla per le sperimentazioni cliniche che utilizzano LaNeo MDMA. Inoltre, PharmAla ha annunciato la nomina di William Avery, CPA, CA come nuovo Direttore Finanziario, con effetto dal 1 ottobre, in sostituzione dell'uscente CFO Carmelo Marelli.
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) ha lanzado una nueva Herramienta de Ensayo Clínico de MDMA para investigadores. Esta herramienta proporciona acceso directo a datos de Química, Manufactura y Control (CMC) y al folleto del investigador de la empresa para investigadores calificados. La iniciativa surge en respuesta a un aumento en las solicitudes de materiales de investigación de MDMA tras la decisión de la FDA sobre la Nueva Solicitud de Medicamento de Lykos para MDMA.
La herramienta, disponible en pharmala.ca/clinical-trials, tiene como objetivo simplificar el proceso para los investigadores que solicitan ensayos con MDMA y aumentar el pipeline de ventas de PharmAla para ensayos clínicos utilizando LaNeo MDMA. Además, PharmAla anunció el nombramiento de William Avery, CPA, CA como el nuevo Director Financiero, efectivo a partir del 1 de octubre, reemplazando al CFO saliente Carmelo Marelli.
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF)는 연구자를 위한 새로운 MDMA 임상 시험 도구를 출시했습니다. 이 도구는 자격 있는 연구자에게 화학, 제조 및 품질 관리(CMC) 데이터와 회사의 연구자 브로셔에 직접 접근할 수 있도록 제공합니다. 이 조치는 Lykos의 MDMA에 대한 신약 신청에 대한 FDA의 결정 이후 MDMA 연구 자료에 대한 요청이 급증함에 따라 이루어졌습니다.
이 도구는 pharmala.ca/clinical-trials에서 제공되며, MDMA로 임상 시험을 신청하는 연구자들을 위한 프로세스를 간소화하고 LaNeo MDMA를 사용한 임상 시험을 위한 PharmAla의 판매 파이프라인을 강화하는 것을 목표로 합니다. 또한, PharmAla는 William Avery, CPA, CA를 새로운 최고 재무 책임자(CFO)로 임명했다고 발표했으며, 이 임명은 10월 1일부터 유효하며, 전 CFO인 Carmelo Marelli를 대체합니다.
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) a lancé un nouvel Outil d'Essai Clinique MDMA pour les chercheurs. Cet outil fournit un accès direct aux données sur la Chimie, la Fabrication et le Contrôle (CMC) ainsi qu'à la brochure des enquêteurs de l'entreprise pour les chercheurs qualifiés. L'initiative fait suite à une augmentation des demandes de matériaux de recherche sur la MDMA après la décision de la FDA concernant la Demande de Médicament Nouvelle de Lykos pour la MDMA.
L'outil, disponible sur pharmala.ca/clinical-trials, vise à simplifier le processus pour les chercheurs postulant à des essais cliniques avec la MDMA et à renforcer le pipeline de ventes de PharmAla pour les essais cliniques utilisant LaNeo MDMA. De plus, PharmAla a annoncé la nomination de William Avery, CPA, CA en tant que nouveau Directeur Financier, à compter du 1er octobre, remplaçant ainsi le Directeur Financier sortant Carmelo Marelli.
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) hat ein neues MDMA-Klinikversuchs-Tool für Forscher eingeführt. Dieses Tool bietet qualifizierten Forschern direkten Zugriff auf Daten zur Chemie, Herstellung und Kontrolle (CMC) sowie auf die Broschüre der Unternehmensforscher. Die Initiative ist eine Reaktion auf den Anstieg von Anfragen nach MDMA-Forschungsmaterialien nach der Entscheidung der FDA über den Antrag auf ein neues Medikament von Lykos für MDMA.
Das Tool, das unter pharmala.ca/clinical-trials verfügbar ist, zielt darauf ab, den Prozess für Forscher zu vereinfachen, die klinische Studien mit MDMA beantragen, und die Vertriebspipeline von PharmAla für klinische Studien mit LaNeo MDMA zu fördern. Darüber hinaus gab PharmAla die Ernennung von William Avery, CPA, CA zum neuen Chief Financial Officer (CFO) bekannt, die ab dem 1. Oktober wirksam wird, und ersetzt den scheidenden CFO Carmelo Marelli.
- Launch of MDMA Clinical Trial Tool for researchers, providing easy access to CMC data and investigator's brochure
- Increased interest from clinical researchers in PharmAla's MDMA products
- Potential growth in sales pipeline for clinical trials using LaNeo MDMA
- Appointment of William Avery, CPA, CA, as new CFO, bringing experience with publicly traded companies in innovative fields
- None.
TORONTO, Aug. 22, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce that it has created a new tool for researchers, providing direct access to its Chemistry, Manufacturing and Control (CMC) data – as well as its investigator’s brochure – to qualified researchers.
“Over the past number of weeks we have seen a massive influx of requests for documentation for research materials for MDMA. One of the unlooked-for effects of the FDA’s decision on the Lykos New Drug Application for MDMA has been a dramatic increase in clinical researchers looking for information about our products. Clearly, MDMA is still of significant interest to the global research community,” said Nicholas Kadysh, CEO, PharmAla Biotech. “Following the successful rollout of PharmAla’s prescriber’s portal for our Canadian prescriber population, we’re pleased to offer this new tool to the global clinical researcher community. We hope it will save them time and energy as they apply for grant funding, and is a testament to PharmAla’s unmatched regulatory transparency and sophistication.”
The new tool, offered at https://pharmala.ca/clinical-trials, offers researchers direct access to drug product quality information, which researchers can examine directly. PharmAla expects that the tool will ease the process for those researchers who wish to apply for trials with MDMA, and help continue to grow PharmAla’s sales pipeline for clinical trials using LaNeo MDMA. Dozens of researchers are already using LaNeo MDMA for clinical research all over the world.
CFO Change
PharmAla Biotech is furthermore pleased to announce that it will be engaging Mr. William Avery, CPA, CA, as Chief Financial Officer for the Corporation, effective October 1st. Mr. Avery has been acting as Financial advisor for PharmAla Biotech for over a month. Mr. Avery is a former partner at MNP, focusing on publicly traded companies in innovative fields.
The Board of PharmAla Biotech extends their thanks to Mr. Carmelo Marelli, the company’s outgoing CFO, for his years of service.
About PharmAla
PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.
For more information, please contact:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Website: www.PharmAla.ca
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmAla’s current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by PharmAla at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. The forward-looking information contained in this press release is made as of the date hereof, and PharmAla is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in PharmAla’s management’s discussion and analysis which is available on PharmAla’s profile at www.sedar.com.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
FAQ
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