Special Access in Australia and internationally will likely be restricted to very small number of ‘last resort’ cases until there have been comprehensive double blind trials. These take time and money to set up including ethics considerations. As well they can take up to three years. So excitement needs to be moderated until ther is a clearer way forward to commercialization. A large pharma might ‘cozy up’ to RCE with support for trials in the US. But is is still a long journey.
Ann: Positive Sinusitis Patient Update - Special Access Scheme, page-86
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