it obviously the study is not suitable for TGA approval. Didn’t u read the announcement? Says it for change of EMDR riules from 2029.
“The results from this study provide significant clinical evidence of the performance of Viraleze™ inhumans that will support regulatory processes for the transition to the new European Medical DeviceRegulations (MDR), which will come into full effect in 2029. The positive data will also support ongoingmarketing and commercial activities for the product.”
it obviously the study is not suitable for TGA approval. Didn’t...
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