WRONG ... Clinical studies are still required to get FDA approval to sell any product.
ANSWER:
http://fdadrugcompliance.com/resources/otc/ Quote: Over-the-counter (OTC) Monograph process Over-the-counter drugs are defined as drugs that are safe and effective for use by the general public without a prescription. There are more than 80 classes (therapeutic categories) of OTC drugs, ranging from acne drug products to weight control drug products. As with prescription drugs, CDER oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks. FDA has been evaluating the ingredients and labeling of these products as part of "The OTC Drug Review Program." The goal of this program is to establish OTC drug monographs for each class of products. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System." FDA's review of OTC drugs is primarily handled by CDER's Office of Nonprescription Drug Products. However, scientists and regulators throughout CDER, the Office of General Counsel, and other Centers within FDA are routinely asked to assist in this massive effort. There is also an advisory committee, "The Nonprescription Drug Advisory Committee," which meets regularly to assist the agency in evaluating issues surrounding these products. Additional information regarding the OTC Monograph Review process can be found at the following URL: • www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm052786.htm
http://www.otcmarkets.com/financialReportViewer?symbol=PHAR&id=70758 Quote: H. The need for any government approval of principal products or services and the status of any requested government approvals. The FDA has approved AQUAPRIN™ for commercialization scale production.
http://www.otcmarkets.com/financialReportViewer?symbol=PHAR&id=46305 Quote: Pharmstar Pharmaceuticals, Inc., a Delaware corporation, (formerly known as Big Star Media Group, Inc.) (Pink Sheets: BMGI) (the “Company”) executed a stock purchase agreement to acquire 93.5% of Pharmstar Pharmaceuticals, Inc., a private Nevada corporation, on March 11, 2011.
The Company has amended its corporate charter to effect the name change from Big Star Media Group, Inc. to Pharmstar Pharmaceuticals, Inc., and is in the process of effecting the name change with FINRA. The Company expects to have a new ticker symbol assigned by FINRA within 2 to 4 weeks.
All former officers and directors have been replaced; Mr. Howard Phykitt is now Chairman of the Board of Directors and is the Company’s Chief Executive Officer.
http://www.investopedia.com/terms/i/insolvency.asp#axzz1jSz87o00 Quote: Definition of 'Insolvency' When an individual or organization can no longer meet its financial obligations with its lender or lenders as debts become due. Insolvency can lead to insolvency proceedings, in which legal action will be taken against the insolvent entity, and assets may be liquidated to pay off outstanding debts.
I am building a summary of PHAR's False and Misleading Reporting for and SEC complaint. - Bogus Accounting Assets - Falsely reporting the Float - Share reduction?
It was the Outstanding that WAS to be reduced. No proof of that yet however. Sometimes the Authorized is reduced as well, but I believe PHAR indicated only a reduction in the Outstanding.
The announced buyback that doesn’t appear to have happened would be just one item that the SEC may be interested in.
ANSWER:
http://www.otcmarkets.com/financialReportViewer?symbol=PHAR&id=70770 Quote: FOURTH. (a) Authorized Capital. The total number of shares of all classes of stock which the Corporation shall have authority to issue 660,000,000 of which 650,000,000 shares, par value of $0.025 shall be designated as Common Stock (“Common Stock”) and 10,000,000 shares, par value of $0.00001 shall be designated as Preferred Stock (“Preferred Stock”).
PHAR does not have ownership of their building. What is taking Howard so long?? Seems that financing is NOT getting done.
ANSWER:
http://www.otcmarkets.com/financialReportViewer?symbol=PHAR&id=70758 Quote: Item X The nature and extent of the issuer’s facilities. 14 Pharmstar owns a research laboratory and small-scale production facility in Wilson NC. The company plans to begin a scaled up production facility for retail distribution in the near future.
Quote: NOTE 5 — COMMITMENTS AND CONTINGENCIES Beginning April 2011 the Company entered into a six-month renewable lease-purchase agreement with S.T. Wooten Corporation for approximately 3.33 acre lot of real property in Wilson County, North Carolina located at 3914 Airport Blvd Wilson, NC 27893 for $6,500 monthly rent. Notwithstanding, the monthly rent does not include payments toward utilities, real property taxes, alterations and improvements, maintenance and repairs, and the minimum $1,000,000 amount of liability insurance coverage requirement.
PHAR is not a startup in the classic sense ... it is a continuation. First patents were filed over 10 years ago.
To call PHAR a startup is disingenuous
CONFIRMATION:
http://www.otcmarkets.com/financialReportViewer?symbol=PHAR&id=70758 Quote: The Company’s newly acquired pharmaceutical business is not a “start-up” operation. The Company’s new management, since 1992, have performed, and continue performing all the costly research, development and packaging engineering, product stability, shelf-life testing and quality-control for AQUAPRIN.
These annual financials are UNAUDITED. No Opinion on them from any accounting firm. Labrozzi NEVER opined on them.
so yeah ... not buying it until Howard delivers.
CONFIRMATION:
http://www.otcmarkets.com/otc-101/otc-market-tiers Quote: OTC Pink™ Current Information Companies that follow the International Reporting Standard or the Alternative Reporting Standard by making filings publicly available through the OTC Disclosure & News Service pursuant to OTC Markets Group Guidelines for Providing Adequate Current Information (pdf) are designated as OTC Pink Current Information. The Current Information category is based on the level of disclosure and is not a designation of quality or investment risk. This category includes shell or development stage companies with little or no operations as well as companies without audited financials and as such should be considered extremely speculative by investors.
http://www.otcmarkets.com/content/doc/DisclosureGuidelines.pdf Quote: Quarterly Reporting Obligations In order to be considered as having adequate current information publicly available, issuers must publish Quarterly Updates to their disclosure statements through the OTC Disclosure and News Service, no later than 45 days after the end of each fiscal quarter. Quarterly Updates should contain responses to the following items, and should follow the format below.
PHAR said the Rollback was DONE ... Quote: ________________________________________ PharmStar Outstanding Common Stock Reduced by 50% October 12, 2012
PharmStar Pharmaceuticals, Inc., (PINKSHEETS: PHAR) (the "Company") today announced that its management and Board of Directors have directed a "rollback" of certain large blocks of shares of PharmStar Pharmaceuticals common stock held by management. This "rollback" was effective as of today.
CONFIRMATION:
http://www.otcmarkets.com/financialReportViewer?symbol=PHAR&id=70770 Quote: FOURTH. (a) Authorized Capital. The total number of shares of all classes of stock which the Corporation shall have authority to issue 660,000,000 of which 650,000,000 shares, par value of $0.025 shall be designated as Common Stock (“Common Stock”) and 10,000,000 shares, par value of $0.00001 shall be designated as Preferred Stock (“Preferred Stock”).
IN WITNESS WHEREOF, I have signed the Amended and Restated Certificate ofIncorporation this 14th day of October, 2011. _____________________________ Howard Phykitt Chief Executive Officer