SEC Comment Letter for ELITE PHARMACEUTICALS (ELTP) — Jan 20, 2012
ELITE PHARMACEUTICALS INC /NV/ (ELTP) (CIK 0001053369)
Date: Jan. 20, 2012 · CIK: 0001053369 · Accession: 0000000000-12-003320
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 001-15697
Letter
January 20, 2012 Via E-mail Mr. Jerry Treppel Chief Executive Officer Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, NJ 07647 Re: Elite Pharmaceuticals, Inc. Form 10-K for the Year Ended March 31, 2011 Filed June 29, 2011 File No. 001-15697
Dear Mr. Treppel:
We have reviewed your filing and have the following comments. In our comments, we ask you to provide us with information so we may better underst and your disclosure.
Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe a comment applies to your facts and circ umstances, please tell us why in your response. Please furnish us a letter on EDGAR under the fo rm type label CORRESP that keys your responses to our comments. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing. General
1. You disclose on page 6 that on March 3, 2011, the U.S. Food and Drug Administration announced its intention to remove approxi mately 500 cough/cold and allergy related products from the U.S. market, including th e Lodrane products which were responsible for 97% and 100% of your revenues for Fis cal 2011 and Fiscal 2010, respectively. We note that the FDA began its Unapproved Dr ug Initiative in June 2006. Prior to this March 3, 2011 announcement, however, it doe s not appear that you disclosed the potential risk that these una pproved drugs may be removed from the market. Given your substantial dependence on unapproved products , please advise us why you believe that this additional disclosure was not necessary in your filings pr ior to the March 3, 2011 announcement.
Mr. Jerry Treppel Elite Pharmaceuticals, Inc. January 20, 2012 Page 2
Management’s Annual Report on Internal C ontrol over Financial Reporting, page 56 2. We note your statement that your management assessed the effectiven ess of your internal control over financial reporting as of Marc h 31, 2011 and determined that there were material weaknesses. Please revise your disclosu re in future filings to state, if true, that your internal control over financ ial reporting was ineffective.
We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made.
In responding to our comments, please provi de a written statement from the company acknowledging that:
the company is responsible for the adequacy an d accuracy of the disclo sure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States.
Please contact Kei Nakada, Staff Accountant, at (202) 551-3659 or Don Abbott, Senior Staff Accountant, at (202) 551-3608, if you have questions regarding the processing of your response as well as any questions regarding co mments on the financial statements and related matters. You may contact Mike Rosenthall, St aff Attorney, at (202) 551-3674 or Jennifer Riegel, Special Counsel, at (202) 551-3575 with ques tions on any of the other comments. In this regard, do not hesitate to contact me at (202) 551-3752.
Sincerely,
/s/ Gus Rodriguez
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January 20, 2012 Via E-mail Mr. Jerry Treppel Chief Executive Officer Elite Pharmaceuticals, Inc. 165 Ludlow Avenue Northvale, NJ 07647 Re: Elite Pharmaceuticals, Inc. Form 10-K for the Year Ended March 31, 2011 Filed June 29, 2011 File No. 001-15697 Dear Mr. Treppel: We have reviewed your filing and have the following comments. In our comments, we ask you to provide us with information so we may better underst and your disclosure. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe a comment applies to your facts and circ umstances, please tell us why in your response. Please furnish us a letter on EDGAR under the fo rm type label CORRESP that keys your responses to our comments. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing. General 1. You disclose on page 6 that on March 3, 2011, the U.S. Food and Drug Administration announced its intention to remove approxi mately 500 cough/cold and allergy related products from the U.S. market, including th e Lodrane products which were responsible for 97% and 100% of your revenues for Fis cal 2011 and Fiscal 2010, respectively. We note that the FDA began its Unapproved Dr ug Initiative in June 2006. Prior to this March 3, 2011 announcement, however, it doe s not appear that you disclosed the potential risk that these una pproved drugs may be removed from the market. Given your substantial dependence on unapproved products , please advise us why you believe that this additional disclosure was not necessary in your filings pr ior to the March 3, 2011 announcement. Mr. Jerry Treppel Elite Pharmaceuticals, Inc. January 20, 2012 Page 2 Management’s Annual Report on Internal C ontrol over Financial Reporting, page 56 2. We note your statement that your management assessed the effectiven ess of your internal control over financial reporting as of Marc h 31, 2011 and determined that there were material weaknesses. Please revise your disclosu re in future filings to state, if true, that your internal control over financ ial reporting was ineffective. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provi de a written statement from the company acknowledging that: the company is responsible for the adequacy an d accuracy of the disclo sure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States. Please contact Kei Nakada, Staff Accountant, at (202) 551-3659 or Don Abbott, Senior Staff Accountant, at (202) 551-3608, if you have questions regarding the processing of your response as well as any questions regarding co mments on the financial statements and related matters. You may contact Mike Rosenthall, St aff Attorney, at (202) 551-3674 or Jennifer Riegel, Special Counsel, at (202) 551-3575 with ques tions on any of the other comments. In this regard, do not hesitate to contact me at (202) 551-3752. Sincerely, /s/ Gus Rodriguez Gus Rodriguez Accounting Branch Chief