technically Par has ran a phase 3 trial (without our optimal dose) and arrived at the conclusion that the lower doses are not performing as strongly as the optimal dose. I call that successful. But each to their own. (yes, Disappointing that Par and the FDA negotiated 2mg out of the stage 1 of the phase 3 while they completed other studies to complete their dataset to quash the adrenal anomaly submitted in the IND).
Also, Paul is on record as saying, Zilosul is a drug that could be used initially to dampen down the pain pathways, regulate the adverse healing, decrease chronic inflammatory state, increase patency of fine capillaries in subchondral bone, preparing the joint for other drugs to perform better.
The analogy he used was a garden hose attempting to put out a bush fire. The OA disease being the bushfire and the other drugs being the garden hose.
What Zilosul does is it get the bushfire under control, allowing the other methods a chance to work on their targets more successfully. As we know OA has many disease processes occurring at once AND not every OA diagnosis is the same.
Zilosul is spesh. We hope the FDA believe it is safe to go mainstream and that PAR have uncovered all the contraindications at 2mg dose subQ.
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