On the road to growth!, page-5

From reading the announcements and analyst reports etc, this is my abridged complete speculation/version of how it’s going to go down in the next 1-2 years. Major talking points only:

* Paradigm with do a deal with Dept. of Defence in the quarter. Either DoD will fund P3 trial for CHIKV or buy PPS supply at around US$3000 to guinea pig their CHIKV affected GI Joes in the Caribbean and Latin America.

* Paradigm will file IND and proceed to P2/3 trial for MPS first. The reason for doing so is because the MPS line has the best chance of being designated breakthrough by the FDA. Real chance of the trial being stopped so all patient participants (including placebo arm) can access PPS. Also, going first retains pricing power for the indication, which will be in the region of $100K per year for this orphan indication.

* Paradigm will file TGA Provisional Approval this quarter for approval and first sales by 2H 2020.

* Paradigm will do a regional deal for OA in Europe and Japan. Europe because already there is injectable PPS in the market and there is a risk for off-label use and reduced pricing power. They will not do a deal for Oz market and will use provisional approval to learn how easy it will be to penetrate the OA market if they go ahead alone. They will be watching Flexion closely who have built out their own US salesforce to push the inferior steroid OA drug in the US market. They will not do a deal for the US in the next 2 years.

* Paradigm will conduct a multi-arm P3 OA trial with a placebo run in. Crucially, all arms will involve patients in the 4-6 strata. MRI scans will be a secondary endpoint in all arms. Several arms will pit PPS against current standard treatment of care such as steroids, analgesics and NSAID’s. Will push for disease modification designation as a result. As soon as they get this - huge implications on deal size. Trial may be stopped early by FDA as breakthrough designation, because, hey, the FDA were putting up with the Anti-NGF drug’s terrible safety profile to solve for the disease.

Big news in three weeks, similar to the pattern of last director buy notices in March.

Writing this for historic purposes. All IMO.