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Pharmacy News Article






11/19/11 - Nature's Bioceuticals Decides To Forgo The Time And Expense of Filing Drug Applications On COPD Formula with FDA And Initiates Production




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."









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