I’m confused about the IP. If the IP already exists, they would transfer full rights to VitaDAO? Or would the agreement be for future IP? The only thing patentable here is the delivery to the knees with the microspheres? Or do they have IP on the current formulation and plan to get more IP on a new formulation in contract to Asphallion? Are there any data with the new formulation?
From a data standpoint, the release doesn’t look like 3 months; more like 2, with the bulk of the release over about 2 weeks. Presumably this is part of the proposed formulation work to refine the microparticles so the logistic curve has a more even release?
Do regulatory agencies buy pre-clinical data like that shown? If I were reviewing those data for a paper, I would not buy the 100 mg/kg/day dose, and want a more reasonable dose done instead. 100 mg/kg daily is 6.8 g/day for a 150# person (assuming exact translation); yet the microsphere dosing is 1-10 ug. Is the oral efficacy just that lousy?
The GW PPARa agonist worked better in the in vitro trials. Why was FN advanced instead of the GW compound?