Ann: Primary Endpoint Achieved in Phase 2 MPS VI Trial, page-39

I personally wonder if there is a silver lining to this announcement.

Given the Zilosul drug is what we call a “dirty drug” with multiple active and inactive moieties AND these moieties give the drug it’s multiple (SAFE) Mechanisms of ACTION, we want to demonstrate to the agencies we know what our drug does and that it is not “some MAGIC soup”.

The lack of certainty around MOA is something the agencies clearly want us to demonstrate and address with them (008 and DMOAD label clarity). We need to bridge the gap here.

Here we again demonstrate our MOA as a pain reliever and a function improver.

The lack of GAGS reduction potentially improves our discussions with the agencies for our OA asset as it defines the drugs MOA as being more targeted on pain relief, broad anti inflammatory, weak vasodilator, weak blood thinner and this combination with other moieties, is what regulates the healing process in OA - cartilage preserver/regrower, subchondral bone marrow oedema reducer/healer, anti inflammatory and regulator of the healing process.

maybe this helps, not hinders our cause!