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): April 1st, 2020
Trxade Group, Inc.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| 000-55218 | 46-3673928 | |
|
(Commission File Number) |
(I.R.S. Employer Identification No.) |
3840 Land O’ Lakes Blvd
Land O’ Lakes, Florida 34639
(Address of principal executive offices zip code)
800-261-0281
(Registrant’s telephone number, including area code)
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 (see General Instruction A.2. below):
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| [ ] | 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:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
|
Common Stock, $0.00001 Par Value Per Share |
MEDS |
The NASDAQ Stock Market LLC (Nasdaq Capital Market) |
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 [X]
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. [ ]
Item 8.01 Other Events
On April 1st , 2020, Trxade Group, Inc. (the “Company”) issued a press release relating to the filing of an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in conjunction with a request to allow the use of a previously unapproved test kit for the Coronavirus (COVID-19). A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K and incorporated by reference herein.
The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K, contains forward-looking statements within the safe harbor provisions under The Private Securities Litigation Reform Act of 1995, and, as such, may involve known and unknown risks, uncertainties and assumptions. These forward-looking statements relate to the Company’s current expectations and are subject to the limitations and qualifications set forth in the press release as well as in the Company’s other filings with the Securities and Exchange Commission, including, without limitation, that actual events and/or results may differ materially from those projected in such forward-looking statements. These statements also involve known and unknown risks, which may cause the results of the Company, its divisions and concepts to be materially different than those expressed or implied in such statements. Accordingly, readers should not place undue reliance on any forward-looking statements. Forward-looking statements may include comments as to the Company’s beliefs and expectations as to future financial performance, events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the Company’s control. More information on potential factors that could affect the Company’s financial results is included from time to time in the “Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s periodic and current filings with the SEC, including the Form 10-Qs and Form 10-Ks, filed with the SEC and available at www.sec.gov and in the “NASDAQ:MEDS” – “SEC Filings” section of the Company’s website at www.trxadegroup.com. Forward-looking statements speak only as of the date they are made. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.
Item 9.01 Financial Statements and Exhibits.
|
Exhibit
No. |
Description | |
| 99.1 | Press Release Dated March 31, 2020 |
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.
| TRXADE GROUP, INC. | ||
| Date: March 31, 2020 | By: | /s/ Suren Ajjarapu |
| Name: | Suren Ajjarapu | |
| Title: | Chief Executive Officer | |
EXHIBIT INDEX
|
Exhibit
No. |
Description | |
| 99.1 | Press Release Dated March 31, 2020 |
Exhibit 99.1
Trxade
Group, Inc. Files FDA Emergency Use Authorization for
Rapid COVID-19 Testing Kit
TAMPA, FL (Access Newswire)– April 1st, 2020 – Trxade Group, Inc. (NASDAQ: MEDS) an integrated drug procurement, delivery and healthcare platform, announces its wholly-owned subsidiary, Integra Pharma Solutions, has filed for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in collaboration with its partnered manufacturer of the SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or when there are no adequate, approved, and available alternatives.
Filing the EUA has dual purposes; first it serves as notification to FDA that Trxade Group will be distributing the test and secondly, if the EUA is approved, it enables Trxade Group to market the product for diagnostic use. Currently, the test is intended to aid in presenting a qualitative overview of antibody presence in patients who have possibly been infected by the Coronavirus (COVID-19).
The rapid test is intended to be administered at the point of care with no additional instrumentation needed. Trxade has announced 20,000 units available for purchase as pre-orders as soon as April 10, 2020. The strategic partnership entered into by Trxade aims to scale distribution efforts to up to 1,000,000 units in order to supply healthcare facilities and provider offices nationwide to assist with providing value-based care.
Features of the SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit:
| ● | This rapid immunochromatography test provides qualitative detection of specific antibodies (IgM and IgG) found to match those of COVID-19 and is not meant solely for diagnostic purposes | |
| ● | Tests are not meant for home use and should be performed under the supervision of a qualified healthcare professional | |
| ● | The novel Antibody Rapid Test Kit begins working from blood drawn with a single pinprick, providing results within 15 minutes | |
| ● | Negative test results do not rule out infection and follow-up testing with molecular diagnostics should be considered in patients with signs and symptoms or recent exposure to the virus |
About Trxade Group, Inc.
Headquartered in Tampa, Florida, Trxade Group, Inc. (Nasdaq: MEDS) is an integrated drug procurement, delivery and healthcare platform that fosters price transparency and thereby improves profit margins for both buyers and sellers of pharmaceuticals. Trxade Group operates across all 50 states with the central mission of making healthcare services affordable and accessible. Founded in 2010, Trxade Group is comprised of four synergistic operating platforms; the Trxade B2B trading platform with 12,100 registered pharmacies, Integra Pharma Solutions virtual wholesale division, affordable telehealth services through its Bonum Health platform and the coordination of a nationwide distribution network through independent pharmacies or mail order delivery via its DelivMeds app. For additional information, please visit us at www.trxade.com, www.delivmeds.com, and www.bonumhealth.com.
Forward-Looking Statements
This press release may contain forward-looking statements, including information about management’s view of Trxade’s future expectations, plans and prospects, within the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 (the “Act”). In particular, when used in the preceding discussion, the words “may,” “could,” “expect,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions are intended to identify forward-looking statements within the meaning of the Act, and are subject to the safe harbor created by the Act. Any statements made in this news release other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of Trxade, its divisions and concepts to be materially different than those expressed or implied in such statements. These risk factors and others are included from time to time in filings made by Trxade with the Securities and Exchange Commission, including, but not limited to, in the “Risk Factors” sections in its Form 10-Ks and Form 10-Qs and in its Form 8-Ks, which we have filed, and file from time to time, with the U.S. Securities and Exchange Commission. These reports are available at www.sec.gov. Other unknown or unpredictable factors also could have material adverse effects on Trxade’s future results and/or could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements which include, among others, the following: a delay in, or the failure of, the FDA’s approval of the test kit described above, the inability to successfully manufacture, ship or control the quality of, the test kit, and the ultimate cost of the production of such test kit. The forward-looking statements included in this press release are made only as of the date hereof. Trxade cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. We undertake no obligation to update publicly any of these forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable laws. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.
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Investor Relations: Simonne Valdez 800-261-0281 IR@trxade.com |
Corporate Communications: www.NetworkNewsWire.com 212.418.1217 Office Editor@NetworkWire.com |