Nature's Bioceuticals Decides To Forgo The Time And Expense of Filing Drug Applications On COPD Formula with FDA And Initiates Production
CAPE CORAL, Fla., Nov. 3, 2011 /PRNewswire/ -- Nature's Bioceuticals, a wholly owned subsidiary of Mistral Ventures Inc. (MILV.pk) announced that it has decided to forgo filing an Investigational New Drug (IND) application and New Drug Application(NDA) with the FDA for the COPD formula. Nature's will instead take immediate steps to begin manufacturing and marketing the COPD Formula as a dietary supplement.
Robert deZanger, CEO of Nature's Bioceuticals stated, "We are confident that our COPD formula should have passed all requirements to be approved by the FDA as a drug. However, after weighing the time it takes for approval and the costs involved we felt it would be in the best interest of the company and the people that can be helped by our formula, to bring it to market as soon as possible. It typically takes 10-15 years and upwards of $300,000,000 to get a drug from the lab to the pharmacy shelf. If we had continued to follow this route the cost of our product to the consumer would have to be substantially higher to cover the costs associated with approval. Also, it would have been many years before our potential customers could have benefited from taking our product. Further, we would have had to raise funds to cover the costs or partner with a big pharma company. We will now be able to manufacture and market the formula immediately so we can start producing revenue. The only substantial change will be that in our marketing, under the Dietary Supplement Health and Education Actof 1994 (DSHEA), we will not be allowed to state that the product is for the treatment of COPD. We anticipate that our revenues could likely exceed $10,000,000.00 year one and $40,000,000.00 year two. As the effectiveness of our formula is documented we expect revenues to increase exponentially."
About Nature's Bioceuticals:
Nature's Bioceuticals develops and acquires the rights to natural medicine formulas that are geared towards treating specific medical conditions. These medicines are all natural and derived from botanicals and mineral bases. Nature's Bioceuticals strives to provide high quality natural medicines that are as effective, if not more effective, than synthetic drugs and more importantly do not have the negative side effects usually associated with many of today's prescribed drugs.
Nature's line of natural medicines will be either sold as prescription drugs, if applied for by the company and approved by the FDA, or sold as dietary supplements under the Dietary Supplement Health and Education Act of 1994, commonly referred to as "DSHEA".
In addition to historical information, this release contains forward-looking statements. Mistral Ventures, Inc. and/or Nature's Bioceuticals may, from time to time, make written or oral forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements encompass Mistral Ventures, Inc. and/or Nature's Bioceuticals beliefs, expectations, hopes, or intentions regarding future events. Words such as "expects," "intends," "believes," "anticipates," "should," "likely," and similar expressions identify forward-looking statements. All forward-looking statements included in this release are made as of the date hereof and are based on information available to the Company as of such date. Neither Mistral Ventures, Inc. nor Nature's Bioceuticals assume any obligation to update any forward-looking statement. Actual results will vary, and may vary materially, from those anticipated, estimated, projected or expected for a number of reasons, including, among others: further reviews of the Company's financial statements by the Company and its Audit Committee; modification of the Company's accounting practices; foreign business risks; industry cyclicality; fluctuations in customer demand and order pattern; changes in pricing and general economic conditions; as well as other risks that may be delineated from time to time or filed with the SEC.
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E-mail: investors@naturesbioceuticals.com
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SOURCE Mistral Ventures Inc.
