Well, that sounds like good news. I hope they get their EPA approvals as well. Here is an excerpt from the Bioshield SEC filings about the government agencies and regulations that they must satisfy with their substantially similar products. I will begin to look up the pre-clinical and clinical data for you.
GOVERNMENT REGULATION; FDA.
The development, manufacture, testing and marketing of all of the Company's products are subject to extensive regulation by numerous authorities in the United States and other countries. In the United States, before new antimicrobial products for humans are permitted to be marketed commercially, they must undergo extensive preclinical and clinical testing to satisfy the FDA that they are safe and efficacious in each clinical indication (the specific condition intended to be treated) for which approval is sought. Additionally, approval by analogous regulatory authorities in other countries must be obtained prior to commencing marketing of healthcare, drug products and medical devices in those countries. The approval process varies from country to country and approval of a drug for sale in one country does not ensure approval in other countries. Delays in obtaining regulatory approvals may adversely affect the development, testing or marketing of the Company's products and the ability of the Company to generate revenues from the sale or licensing of such products. There can be no assurance that regulatory approvals will be obtained by the Company in the United States or any other country to sell its products for such purposes.
Manufacturers of therapeutic products sold in the United States are required to satisfy the FDA that their manufacturing facilities and processes adhere to the agency's Good Manufacturing Practices ("GMP") regulations and to engage in extensive record keeping and reporting. Even if regulatory approval for a product is granted, the facilities in which the product is manufactured will be subject to periodic review and inspections by the FDA or the analogous regulatory authorities of other countries for compliance with GMP or similar foreign regulatory standards. Compliance with such regulations requires substantial time and attention, and is costly. In addition, each domestic manufacturing establishment must be registered with and approved by the FDA. For biologics, except certain well-characterized ones, this requires the filing of an establishment license application for the facilities at which the product will be produced. Failure to comply with the applicable regulatory requirements by either the Company or its strategic partners could, among other things, result in criminal prosecution and fines, product recalls, product seizures and operating restrictions. The Company has not yet sought FDA approval for the commercial sale of any of its products or for the manufacturing processes or facilities of any of its strategic partners. Moreover, even if approval is granted, such approval may impose limitations on the indicated uses for which a product may be marketed.
Inasmuch as the Company may manufacture products in the United States and seek to market or license other domestic manufacturers to market products throughout the world, the Company may become subject to United States laws and regulations applicable to exporting drugs, including biologics. The Federal Food, Drug, and Cosmetic Act stipulates that, prior to FDA approval for commercial sale, a drug manufactured in the United States may be exported to any country in the world, without prior FDA authorization, only if it has received marketing authorization in at least one of the 25 countries listed in Section 802 of that act. Other requirements include that (i) the product is manufactured in substantial compliance with the FDA's GMP regulations, (ii) the FDA is notified of the exportation, and (iii) the FDA has not determined that the probability of reimportation presents an imminent hazard to the public health and safety of the United States. Drugs for investigational use in any of the 25 countries may be exported without notification to the FDA. Drugs for investigational use in other countries may not be exported without FDA authorization. Thus, the ability of the Company or its licensees to export products manufactured in the United States prior to receiving commercial approval in the United States will be subject to certain restrictions. Therefore, there can be no assurance that the Company or its licensees would be able to export for investigational use or commercial sale in any countries, products manufactured in the United States which have not received FDA approval.
GOVERNMENT REGULATION; EPA.
The Company is also subject to the regulations of the United States
Environmental Protection Agency as well as other federal, state and local laws and regulations governing pesticides and antimicrobial products. Compliance with these laws and regulations is time-consuming, expensive and failure to receive timely approval or approval at all could have a material adverse effect on the Company. In May of 1997, the Company made applications to the EPA for registration of BioShield AM500 and AM500I and intends to submit an application to the EPA for registration of BioShield AM36.OI and AM3651P to enable it to make certain claims regarding the antimicrobial properties of certain of its products. No assurance can be given that the EPA will approve any or all of such claims. The adoption by federal, state or local governments of significant new laws or regulations or a change in the interpretation of existing laws or regulations relating to environmental or other regulatory matters could increase the cost of producing the products manufactured by the Company or its strategic partners or otherwise adversely affect the demand for the Company's products. Adverse governmental regulation which might arise from future legislative or administrative action cannot be predicted. See "Business-Government Regulation."
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