Company: MDCXW
Filing Date: 2025-09-19
Form Type: DRS
Source: 0001062993-25-015719
Chunk: 120

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-19
Form: DRS
Chunk 120
---
 bag, which contains D-MNA's of the same dosage (25 µg, 50 µg, 100 µg, or 200 µg, or placebo). The outer Uline bag is sealed with a serialized security tape and carries standard investigation drug labeling (Figure 7) including a supplemental label containing the subject number.

<div align='center'>Figure 8. 4" x 6" Ziplock Uline Bag with Serialized Security Strip</div>

When the packaging of the entire production run (consisting typically of 200-240 arrays) has been completed, the product is then shipped on ice pack for the next phase, namely, sterilization, quality control testing, and release of the product.

Release Testing and Release of Product

The release of GMP-quality product to a clinical site is a highly regulated practice. Upon shipping of the arrays form GFE, LLC, the array manufacturer, which has already performed its own quality control, the entire shipment of arrays embarks on a multistage process, whose end goal is release of the investigational product to the clinical site (Figure 8).

Because the arrays are breaking the skin surface of human subjects, the FDA views the arrays as a type of parenteral product and therefore requires sterilization. On the day of completing the packaging of the arrays, GFE ships the fully packaged arrays by overnight courier to Ebeam Services who performs electron beam sterilization of the arrays. The arrays are then transported by a same-day courier service from Ebeam Services to Intertek Pharmaceutical Services ("Intertek"), who performs four functions:

1)places the majority of the arrays in stability storage;

<div align='center'>77

CONFIDENTIAL TREATMENT REQUESTED BY MEDICUS PHARMA LTD.PURSUANT TO 17 C.F.R. SECTION 200.83</div>

2)ships a designated number of arrays to Nelson Laboratories for endotoxin and bioburden testing;

3)initiates analytical and other testing of the arrays within Intertek; and

4)ships a designated number of the arrays to Clinigen on quarantine for distribution to the clinical sites when the arrays have passed quality control/quality assurance.

<div align='center'>Figure 9. Release procedures for Microneedle Arrays</div>

Figure 10 indicates the types of tests performed for release of the product.

<div align='center'>Figure 10. Certificate of Analysis qualifying the release of microneedle arrays</div>

The essential settings for the