Considering the time and effort that has gone into this proposal only to have it rejected holds concern for other products that may be submitted in the future. It has been a concern of mine for a long period of time that the benefits of artimist in saving lives in third world countries has been demonstrated in trials yet no major or minor pharmaceutical in the last 10 years has been prepared to pick it up. TGA approval was meant to be the turning point. There is something fundamentally wrong with either the product or the company and TGA rejecting the proposal only supports this. Whatever happens SUDA needs to get this over line, learn from it and move forward. If they are unable to do this then it is time to move on.
Ann: ArTiMist Regulatory Update, page-62
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