BRIGHT MINDS BIOSCIENCES INC.
For the period ended Sep 30, 2025. Filed Dec 23, 2025.
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The yearly report of certain Canadian companies, filed under a joint US and Canadian system. It is the main yearly account these companies give US investors, largely as filed in Canada.
FY2025 · Filed Dec 23, 2025
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Contents
EX-99.1 · Regulatory Framework
Regulatory Framework
Drug products must be approved by the appropriate governing body before it can be sold in that country or area. The FDA approves products for the United States market and Health Canada approves products for the Canadian market. The European Medicines Agency approves products for the European Union. While the process by which products are approved by the FDA and Health Canada is very similar, each regulatory body has its own unique requirements for a product. In both cases, the development of a product through to approval can be a lengthy process and, in some cases, can take over 10 years. While early studies conducted in one jurisdiction will usually be accepted in the other, further and somewhat modified studies may be required to have a product approved in another jurisdiction.
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