POLICY DRAFT
Expanded Access Policy for MT027
T-MAXIMUM Pharmaceutical Inc.
T-MAXIMUM Pharmaceutical Inc. ("T-MAXIMUM" or the "Company") is developing MT027, an investigational biological product. MT027 has not been approved by the U.S. Food and Drug Administration (FDA), and FDA has not determined that MT027 is safe or effective for any use.
This policy describes how T-MAXIMUM evaluates unsolicited requests from licensed treating physicians for individual-patient access to MT027 outside a clinical trial in the United States. It does not establish a routine, cohort, or widespread expanded access program and does not apply to participation in a clinical trial, post-trial access governed by a clinical protocol, or access under another country's laws.
T-MAXIMUM may apply a separate policy or additional requirements to a request outside the United States. Any such request must comply with the laws and regulatory requirements of the country in which treatment would occur.
T-MAXIMUM's priority is to conduct the clinical trials needed to determine the safety and effectiveness of MT027 and, if supported by the evidence, to seek regulatory approval so that the product may become broadly available. Participation in a clinical trial is the preferred route for access to MT027 whenever an appropriate trial is available and the patient is eligible and able to participate.
Information about the T-MAXIMUM-sponsored MT027 study is available at ClinicalTrials.gov: NCT07386002 - The GLIOMAX Study. Trial status, locations, and eligibility information may change and should be confirmed directly in the current record and with the study contact.
As of the effective date of this policy, T-MAXIMUM has not established a routine or cohort expanded access program for MT027. The Company may nevertheless, in its sole discretion, evaluate an unsolicited individual-patient request submitted by a licensed treating physician.
Requests will be considered individually, fairly, and carefully based on the information available at the time. Posting this policy does not guarantee access, Company support of a request, availability or supply of MT027, or any particular clinical outcome. A decision to support one request does not create a precedent or obligation to support another request.
Only a licensed treating physician should submit an individual-patient expanded access request. Patients and family members should discuss potential clinical trials and expanded access with the patient's treating physician.
The treating physician should contact T-MAXIMUM at:
Expanded access email: [info@t-maximum.com] Suggested subject line: MT027 Expanded Access Request - Physician Inquiry
The initial request should contain enough information for a preliminary review, including:
☐ the physician's name, institution, licensure jurisdiction, telephone number, and email address;
☐ a concise, de-identified description of the patient's diagnosis, disease status, relevant medical history, prior treatments, and current clinical condition;
☐ an explanation of why approved or otherwise satisfactory treatment options are unavailable or inappropriate;
☐ an explanation of why participation in an appropriate clinical trial is unavailable, infeasible, or the patient is ineligible;
☐ the scientific and medical rationale for the proposed use of MT027, including the proposed treatment plan;
☐ the treatment site's relevant capabilities and the physician's ability to assume applicable sponsor-investigator and investigator responsibilities; and
☐ any other information reasonably requested by T-MAXIMUM to evaluate the request.
Direct patient identifiers should not be sent by ordinary email. T-MAXIMUM may establish a secure method for any additional patient-level information needed for review.
T-MAXIMUM anticipates acknowledging receipt
of a request within five business days after it reaches the monitored expanded
access contact. This is an estimate for acknowledgment of receipt only. It is not a
representation that the request is complete, an agreement to provide MT027, or
a commitment to reach a decision within any particular period. Additional
information may be required. T-MAXIMUM does not currently support emergency
individual-patient expanded access requests.
Once
sufficient information has been received and reviewed, T-MAXIMUM will
communicate to the treating physician whether the Company is able to support
the request and any conditions associated with such support.
T-MAXIMUM may consider a request only when, based on the information then available, the Company determines that the request is sufficiently supported. Factors may include, without limitation:
☐ the patient has a serious or immediately life-threatening disease or condition;
☐ there is no comparable or satisfactory alternative therapy available for the patient;
☐ the patient cannot obtain MT027 through an available clinical trial or another existing IND or protocol;
☐ there is a scientifically and medically reasonable basis for the proposed use, dose, schedule, route of administration, and monitoring plan;
☐ the potential benefit for the individual patient may justify the potential risks in the context of the disease or condition;
☐ available clinical and nonclinical information is sufficient for T-MAXIMUM to assess the request;
☐ supporting the request would not interfere with or compromise the initiation, conduct, completion, or integrity of clinical trials or the broader development and regulatory program for MT027;
☐ sufficient conforming product, manufacturing capacity, quality oversight, personnel, and other resources are available without jeopardizing clinical trial participants or product development;
☐ the treating physician and treatment site are appropriately qualified and capable of administering the product, managing product-specific and procedure-related risks, maintaining required records, and completing safety and other required follow-up;
☐ all applicable FDA, institutional review board (IRB), informed-consent, privacy, biosafety, institutional, and other legal or regulatory requirements can be met; and
☐ the physician and institution agree to comply with the treatment plan, product handling requirements, safety reporting, outcome reporting, product accountability, and any long-term follow-up obligations specified by T-MAXIMUM, FDA, or the IRB.
These criteria are general considerations, not an entitlement or exhaustive checklist. Meeting them does not require T-MAXIMUM to support a request.
T-MAXIMUM may decline, defer, suspend, or discontinue support for a request for any lawful reason, including concerns relating to patient safety, benefit-risk, scientific rationale, available evidence, product quality, manufacturing or supply, clinical-trial priority, development strategy, regulatory requirements, site capability, operational feasibility, resource limitations, equitable allocation, or new information about MT027.
T-MAXIMUM may also revise, replace, suspend, or withdraw this policy at any time. The version posted on the Company's public website controls at the time a request is evaluated. If support for an ongoing expanded access use must change, T-MAXIMUM will work with the treating physician and applicable authorities on an appropriate safety-focused transition, subject to available product, clinical circumstances, and legal requirements.
A
preliminary decision by T-MAXIMUM to support a request does not authorize
shipment or administration of MT027. Before treatment may begin, all
requirements applicable to the selected expanded access pathway must be
satisfied, including applicable FDA submission and authorization requirements,
IRB review or notification, informed consent, institutional approvals, product
release and shipping requirements, and an agreed monitoring and reporting plan.
If a treating physician submits a separate individual-patient expanded access
IND, T-MAXIMUM may, as appropriate, provide a Letter of Authorization
permitting FDA to reference relevant information in T-MAXIMUM's IND.
The treating physician is responsible for the patient's clinical care and applicable investigator obligations and, when acting as a sponsor-investigator, applicable sponsor obligations. Where T-MAXIMUM sponsors an expanded access protocol under its existing IND, T-MAXIMUM retains the applicable sponsor responsibilities. T-MAXIMUM does not provide medical advice to patients through this policy.
This policy is informational and does not constitute a promise, offer, recommendation, or guarantee. MT027 is investigational. Its risks and potential benefits continue to be evaluated, and the product may not be effective and may cause serious or unexpected adverse effects.
T-MAXIMUM may revise the criteria, contact information, or other elements of this policy as the development program, evidence, supply, laws, regulations, or Company capabilities change. The effective date and version should be updated whenever the public policy is revised.