Hard to Treat Diseases' (HTDS) MMR Vaccine Passed the Chinese SFDA's 'First Drug Evaluation'
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.
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.
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SOURCE Hard to Treat Diseases
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