Yes, very interesting indeed.
FDA will want to know what the minimally effective dose is, so PAR will have this covered with 1mg twice weekly, 1.5 mg twice weekly and 2mg twice weekly dosing regimes across both 008 and 002 trials.
The exploratory endpoints are definitely DMOAD related, so we'd have both the biomarker data and comprehensive screening of joints to support DMOAD action.
PAR also has the placebo effect covered quite well with the added exclusion criteria and the 2mg dose + placebo dosing regime.
The good news is it'll be difficult for PAR to not meet the primary endpoint from both 002 and 008 based on how the trials have been designed, so we should get some positive readouts before all of the DMOAD data drops.
US recruitment should not be far away since the sites are now listed - the next big milestone.
I'm not expecting a cap raise now until Nov 2022 or March 2023, assuming PAR does not obtain funding from elsewhere first.
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