I’m interested in getting views on where in the process Paradigm is for TGA provisional approval.
In the latest release they state:
”File initial submission with the TGA for Provisional Approval Application of ZilosulÒ (iPPS)for treatment of osteoarthritis, Q3 CY 2019”
Would that mean they have already done pre-determination meeting and determination submission?
Reading the process on TGA.gov.au is a bit perplexing. Any views welcomed...ta
Ann: PARADIGM FILES FIRST IND WITH US FDA, page-15
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