ADMA BIOLOGICS, INC. (NASDAQ:ADMA) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
As reported in a Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on December 20, 2018, on December 19, 2018, ADMA Biologics, Inc., a Delaware corporation (the “Company”), issued a press release announcing that the U.S. Food and Drug Administration has issued a Complete Response Letter (the “CRL”) for the drug substance Prior Approval Supplement (“PAS”) submission for BIVIGAM® (Intravenous Immune Globulin [Human], 10%) (“BIVIGAM®”) and previously approved the drug product PAS submission for BIVIGAM®.
On December 20, 2018, the Company held a conference call at 9:00am Eastern Time (the “Conference Call”) to provide more detail about the CRL.
A copy of the transcript of that call is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and contained in the transcript furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is not incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Cautionary Note Regarding Forward Looking Statements
This Current Report on Form 8-K contains “forward-looking statements” to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the Company. These forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements concerning the Company’s plans to develop, manufacture, market, launch and expand its commercial infrastructure, the expected timing of, and the Company’s ability to, obtain and maintain regulatory approvals of its current products and product candidates and the Company’s expectations for future capital requirements. Actual events or results may differ materially from those events or results that may be implied by these forward-looking statements due to a number of important factors. There can be no assurances that the forward-looking statements included will prove to be accurate. Except to the extent required by applicable laws or rules, the Company does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in the Company’s filings with the SEC, including the Company’s most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.
On December 20, 2018, the Company issued a press release announcing that it would be hosting the Conference Call to discuss the CRL received on December 19, 2018.
The full text of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
ADMA BIOLOGICS, INC. Exhibit
EX-99.1 2 e618112_ex99-1.htm ADMA Biologics,…
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About ADMA BIOLOGICS, INC. (NASDAQ:ADMA)
ADMA Biologics, Inc. is a late-stage biopharmaceutical company that develops, manufactures and intends to market specialty plasma-based biologics for the treatment and prevention of infectious diseases. The Company is engaged in the development and commercialization of human plasma and plasma-derived therapeutics. Its segments include Plasma Collection Centers, which includes its operations in Georgia; Research and Development, which includes its plasma development operations in New Jersey, and Corporate. Its targeted patient populations are immune-compromised individuals suffering from an underlying immune deficiency disorder or may be immune-suppressed for medical reasons. Its product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients at risk of contracting infectious diseases. Its intravenous immunoglobulin product candidate, RI-002, is intended for the treatment of primary immune deficiency disease.