Charting view, page-162

hi soldier,

only commentary i could find (promptly enough) is below... PAR never mention fast track for TGA.

10.09.19 release re IND clearance:

• Paradigm’s future submissions include;
o TGA Provisional Approval (Australia),

07.08.19 release re filing first IND with FDA:

File initial submission with the TGA for Provisional Approval Application of ZilosulÒ (iPPS) for treatment of osteoarthritis, Q3 CY 2019;

28.06.19 eoy corp update:

Paradigm expects to file initial submission for Provisional Approval with the Australian TGA which, if approved, would provide potential first revenue and sales in Australia.
File submission with the TGA for Provisional Approval Application of ZilosulÒ for treatment of osteoarthritis, Q3 CY 2019;


perhaps confusion from 51 capital, where they've stated the below (from their 05.06.18 report https://hotcopper.com.au/posts/39443980/single)

With a strong likelihood of being fast-tracked and receiving provisional approval by the FDA and TGA respectively, Zilosul® is potentially 18 months away from commercial sales.

i think they mean fast tracked for FDA, and just provisional approval for TGA.