Company: AIBT
Filing Date: 2025-04-11
Form Type: 10-K
Source: 0001096906-25-000487
Chunk: 10

Company: AIBOTICS, INC.
Filing Date: 2025-04-11
Form: 10-K
Item: Item 1
Chunk 10
---
 manufacturing of the active pharmaceutical ingredient and production of dosage forms. The DEA may adjust aggregate production quotas a few times per year, and individual manufacturing or procurement quotas from time to time during the year, although the DEA has substantial discretion in whether or not to make such adjustments for individual companies.

The states also maintain separate controlled substance laws and regulations, including licensing, recordkeeping, security, distribution, and dispensing requirements. State authorities, including boards of pharmacy, regulate use of controlled substances in each state. Failure to maintain compliance with applicable requirements, particularly as manifested in the loss or diversion of controlled substances, can result in enforcement action that could have a material adverse effect on our business, operations and financial condition. The DEA may seek civil penalties, refuse to renew necessary registrations, or initiate proceedings to revoke those registrations. In certain circumstances, violations could lead to criminal prosecution.

On November 17, 2022, U.S. Senators Cory Booker (D-N.J.) and Rand Paul (R-KY) introduced the Breakthrough Therapies Act, a bipartisan bill that, if passed, would permit the DEA to reclassify a Schedule I drug – defined by the DEA as a drug with “no currently accepted medical use and a high potential for abuse” – that receives a Breakthrough Therapy Designation from the Food and Drug Administration (FDA) to a Schedule II drug under the federal Controlled 

7

Substances Act (CSA). Currently, psychedelics, such as LSD, MDMA, psilocybin, and others, are classified as Schedule I substances. The bill has been referred to the Senate Judiciary Committee.

The Phill Robot and Milkyway are not subject to FDA regulation and are not marketed as medical devices. They are however, subject to regulation that covers all consumer products.