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Friday, 12/20/2019 11:44:16 AM

Friday, December 20, 2019 11:44:16 AM

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Provisional Approval??

My understanding is that there is a new process in Australia that can accelerate the approval of promising drugs after a successful Phase 2 study whereby you can begin selling the drug and continue collecting data into a phase 4 to achieve final approval.

Since DMAC increased the stroke study to 100 patients which is supposed to report topline phase 2 results data in 1Q/20, I'm wondering if they are applying for this "provisional approval?"

Any information or thoughts about this possibility would be appreciated.
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