RE: What exactly does 'pathway' mean?9 Feb 2017 12:37
MTT - the reg pathway is essentially a platform of requitements needed to commercialise a drug. OTC's must be low risk, low addiction and require fast supply/demand and pass CMC (Chemistry Manufacturing Controls). Prescription medicines can have a higher risk and addiction rate as a doctor controls them.
OXP will have to write an IND to platform OXPZero but other than that the drugs inside OXPZero tech are old already proven medicines.
From my knowledge the formulation has had tox, PK and has had successful clinical data to lower GI irritation.
Only one failed clinical result occurred during the 2015 rally and it was by a whisker (p value 0.07 rather than needed 0.05) and I think OXP have improved the formulation since then.
Again, not new drugs, no NDA needed or phase 3 trials.
When a drug enters 2nd gen or 3rd gen production - all you need to do is a bridging study and PK data to show the drug works like the 1st gen.
FDA will have to audit the manufacturer and that is why OXP want commercial partners. Building a to code comm scale manufacturing plant would take time and money and OXP probably dont have all that expertise they seem to be morr discovery than pilot plant based.
Comm partner have the expertise and have the machinery and buildings already to FDA expectations and alls a go go.
This is much closer to commercialisation than the usual 10 year average of pharmas.
Wouldnt surprise me if we saw at least scale up and 1st gen products in 2018