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PVCT Provectus Biopharmaceuticals
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Company plans to seek end-of-phase meeting with Australia’s Therapeutic Goods Administration in Q1 2021“.... for the treatment of symptomatic neuroendocrine tumors (NET) metastatic to the liver (mNET) refractory to somatostatin analogs (SSAs) and peptide receptor radionuclide therapy (PRRT).“ http://www.provectusbio.com/news/press-releases/provectus-pr-20201005-1/ Australia fast track approval pathways: “Provisional approval We can give provisional approval to medicines which provide a promising treatment for a serious or life threatening condition. This makes the medicine available for a limited period while the pharmaceutical company completes final clinical trials. Under the standard pathway, a medicine is not available until after all clinical trials have been completed, so this can make a medicine available up to two years earlier than normal.” http://www.tga.gov.au/fast-track-approval-pathways |
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