PharmaTher Holdings Ltd. (PHRRF on OTCQB and PHRM on CSE), a specialized pharmaceutical firm, has received a Complete Response Letter (CRL) regarding its Priority Original Abbreviated New Drug Application (ANDA) for Ketamine from the U.S. Food and Drug Administration (FDA). The application was accepted and assigned a Generic Drug User Fee Amendments of 2022 (GDUFA) goal date of April 29, 2024.

PharmaTher Holdings Ltd.（OTCQB上的PHRRF和CSE上的PHRM）是一家专业制药公司，已收到美国食品和药物管理局（FDA）关于氯胺酮优先原始缩写新药申请（ANDA）的完整回复信（CRL）。该申请被接受并分配了2022年仿制药用户费用修正案（GDUFA）的目标日期2024年4月29日。

The CRL mirrors the previous review letter issued by the FDA, highlighting Quality-related concerns disclosed on February 12, 2024, with no new deficiencies mentioned. The Company has addressed these issues by conducting necessary tests and formulating responses, which will be submitted to the FDA for further evaluation, leading to a revised GDUFA goal date.

CRL反映了FDA之前发布的审查函，强调了2024年2月12日披露的与质量相关的问题，没有提到新的缺陷。该公司通过进行必要的测试和制定响应来解决这些问题，这些响应将提交给FDA进行进一步评估，从而修订了GDUFA的目标日期。

Updates will be provided accordingly.Fabio Chianelli, CEO of PharmaTher, expressed optimism despite the delay, stating, 'We are pleased that the FDA review of our ANDA has been completed without additional deficiencies. We have responded to the FDA's comments and are ensuring our responses accurately address their concerns.

将相应地提供更新。PharmaTher首席执行官法比奥·奇亚内利（FabioChianelli）表示乐观，尽管有延误，他说：“我们很高兴FDA对我们的ANDA的审查已经完成，没有额外的缺陷。我们已经回应了FDA的评论，并确保我们的回应准确地解决了他们的担忧。

Our aim to obtain FDA approval for ketamine is progressing.'The Company's primary objective is to alleviate the ketamine shortage in the U.S. by adhering to FDA manufacturing guidelines and approved prescribing labels. Upon FDA approval and U.S. launch, international approvals will be pursued to meet global demand.

我们获得FDA批准氯胺酮的目标正在取得进展。”该公司的主要目标是通过遵守FDA的生产指南和批准的处方标签来缓解美国氯胺酮的短缺。在FDA批准和美国上市后，将寻求国际批准以满足全球需求。

Long-term strategies include exploring novel applications and delivery methods for ketamine in pain management, mental health, and neurological disorders.Ketamine, an essential medicine listed on the WHO Essential Medicines List, has been experiencing shortages since February 2018 in the U.S. and since February 2023 in Canada.

长期策略包括探索氯胺酮在疼痛管理，心理健康和神经系统疾病中的新应用和递送方法。氯胺酮是世卫组织基本药物清单上列出的一种基本药物，自2018年2月以来，美国和2023年2月以来，加拿大一直面临短缺。

Health Canada has approved ketamine for sedation and pain relief in ho.

加拿大卫生部已批准氯胺酮用于ho的镇静和止痛。