8-K
Radnostix Inc (INIS)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 10, 2020
INTERNATIONAL ISOTOPES INC.
(Exact Name of Registrant as Specified in Its Charter)
| Texas | 0-22923 | 74-2763837 |
|---|---|---|
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 4137 Commerce Circle<br><br> <br>Idaho Falls, Idaho | 83401 | |
| --- | --- | |
| (Address of Principal Executive Offices) | (Zip Code) |
208-524-5300
(Registrant’s Telephone Number, Including Area Code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act: None
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
| Item 7.01. | Regulation FD Disclosure. |
|---|
On February 10, 2020, International Isotopes Inc. (the “Company”) issued a press release announcing that it has received approval from the U.S. Food and Drug Administration (FDA) for its SODIUM IODIDE I-131 pharmaceutical product. SODIUM IODIDE I-131 is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and carcinoma of the thyroid. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release, dated February 10, 2020. |
| 2 | |
| --- |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| INTERNATIONAL ISOTOPES INC. | ||
|---|---|---|
| Date: February 13, 2020 | By: | /s/ Steve T. Laflin |
| Steve Laflin<br><br> <br>President and Chief Executive Officer |
3
Exhibit 99.1
Exhibit 99.1
FOR IMMEDIATE RELEASE:
February 10, 2020
INTERNATIONALISOTOPES INC. ANNOUNCES
U.S.FOOD AND DRUG ADMINISTRATION
APPROVALOF THEIR ANDA FOR
SODIUMIODIDE I-131
Idaho Falls, ID. February 10, 2020 – International Isotopes Inc. (OTCQB: INIS) (the “Company”) is pleased to announce it has received approval from the U.S. Food and Drug Administration (FDA) for its SODIUM IODIDE I-131 pharmaceutical product. SODIUM IODIDE I-131 is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and carcinoma of the thyroid. The American Cancer Society estimates more than fifty thousand adults in the United States are diagnosed with thyroid cancer each year.
Steve T. Laflin, President and CEO of the Company, said, “We are very pleased to have gained FDA approval of this important pharmaceutical product, which is the only FDA approved generic product of its type manufactured in the United States. INIS has long established itself as a reliable supplier of radiochemicals and we have earned a reputation for high quality products and excellent customer service. Extending our reach to provide FDA approved products is a logical extension of our current supply arrangements. INIS has several additional products at various stages of development in our pipeline. With the successful FDA approval of our first pharmaceutical product, we look forward to utilizing SODIUM IODIDE I-131 as a springboard to advance additional products we have under development. SODIUM IODIDE I-131 will be an important addition to the Company’s product offerings, and we anticipate launching commercial distribution in the very near future.”
About INIS’s Sodium Iodide I-131Product
Radiochemical Sodium Iodide I-131 is utilized for the preparation of sodium iodide I-131 capsules and solution. To use Sodium Iodide I-131 safely and effectively please see the full prescribing information for Sodium Iodide I-131 included in product labeling as well as all warnings, precautions, possible adverse reactions, and drug interactions.
About International Isotopes Inc.
International Isotopes Inc. manufactures a full range of nuclear medicine calibration and reference standards and provides radiochemicals for clinical research and life sciences. The Company also produces a variety of cobalt-60 products such as teletherapy sources and performs contract manufacturing of select radiopharmaceutical products for clients.
Forward-Looking Statements
Certain statements in this press release are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, but not limited to, the expectations for product sales of the new FDA approved product. Information contained in such forward-looking statements is based on current expectations and is subject to change. These statements involve a number of risks, uncertainties and other factors that could cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Other factors, which could materially affect such forward-looking statements, can be found in the Company’s filings with the Securities and Exchange Commission at www.sec.gov, including our Annual Report on Form 10-K for the year ended December 31, 2018. Investors, potential investors and other readers are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements made herein are only made as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
FOR MORE INFORMATION CONTACT:
David Drewitz
Creative Options Communications
Investor and Public Relations
www.creativeoptionsmarketing.com
Phone: 972-814-5723
For more information, please visit the Company web site: www.intisoid.com
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