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On November 2, 2009, State Food and Drug Administration held a Drug Evaluation Conference to determine, whether HTDS' MMR vaccine meets the requirements for release onto the Chinese pharmaceutical market. HTDS' experts and representatives from the manufacturer (Serum Institute of India Ltd.) presented the MMR attenuated vaccine to the SFDA's expert panel. The HTDS' MMR vaccine received a "pass" on its First Drug Evaluation.
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Based on the research and clinical trial results presented, the panel concurred that the Mellow Hope's MMR vaccine had a good safety profile, therefore, the vaccine will undergo further inquiry for the final SFDA approval. The First Drug Evaluation panel will submit the results for final approval. This approval will secure HTDS the production license for MMR vaccine.
Thrilled by the results, HTDS' CEO Terry Yuan said "We got the first "Pass" through this conference and this gives us much confidence to get the final approval. Now we are actively preparing for the clinical trial protocol designed exactly as per Chinese actual conditions. Taking the booster immunization into account, it is estimated that the market size in China will be 60 million doses per year."
Hard to Treat Diseases (HTDS) operates two medical subsidiaries in Europe and Mainland China. HTDS is a parent company with operations in East European Serbia based pharmaceutical company Slavica Bio Chem Co. and in China Mellow Hope Inc.
In other company news, the issuer also brings attention to its two separate filing on Pink Sheets of even date.
http://www.pinksheets.com/pink/quote/quote.jsp?symbol=htds
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Safe Harbor Statement
Information in this news release may contain statements about future expectations, plans, prospects or performance of Hard to Treat Diseases Inc. that constitute forward-looking statements for purposes of the Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995. The words or phrases "can be", "expects", "may affect", "believed", "estimate", "project" and similar words and phrases are intended to identify such forward-looking statements. Hard to Treat Diseases Inc. cautions you that any forward-looking information provided by or on behalf of Hard to Treat Diseases Inc. is not a guarantee of future performance. None of the information in this press release constitutes or is intended as an offer to sell securities or investment advice of any kind. Hard to Treat Diseases Inc.'s actual results may differ materially from those anticipated in such forward-looking statements as a result of various important factors, some of which are beyond Hard to Treat Diseases Inc.'s control. In addition to those discussed in Hard to Treat Diseases Inc.'s press releases, public filings, and statements by Hard to Treat Diseases Inc.'s management, including, but not limited to, Hard to Treat Diseases Inc.'s estimate of the sufficiency of its existing capital resources, Hard to Treat Diseases Inc.'s ability to raise additional capital to fund future operations, Hard to Treat Diseases Inc.'s ability to repay its existing indebtedness, the uncertainties involved in estimating market opportunities, and in identifying contracts which match Hard to Treat Diseases Inc.'s capability to be awarded contracts. All such forward-looking statements are current only as of the date on which such statements were made. Hard to Treat Diseases Inc. does not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.
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SOURCE Hard to Treat Diseases
