Slight grammatical correction:WET Biomarkers (TnfA, Args etc)...

Slight grammatical correction:

WET Biomarkers (TnfA, Args etc) werebettercompared to 1 week dosing
WOMAC Observations did better with 2 a week dosing.

...is meant to be:

WET Biomarkers (TnfA, Args etc) werebetter in the once a week dosing compared to the twice a week dosing
WOMAC Observations did better with the twice a week dosing.

Also, my second chart from the poster disappeared!


Just to reiterate, we need to see the 6 month data, how does that correlate to these observations. Ultimately, in only my opinion, we primarily need WOMAC pain and function improvements for our main trial, this is the primary observations of importance. Then we need the biomarkers to head in the right direction, but it is the STRUCTURAL endpoints and observations that will be key....in a way it doesn't matter as much what and when the biomarkers do their stuff as long as the structural markers improve....Of course they are still important,
the biomarkers , well some of them are highly prognostic...they predict where things are heading and what's going on within the joint......but they are ancillary to the primary endpoints and will establish an overall dossier to be presented to the umpire(s).


The patients, the FDA, the EMA, the TGA (and the Canadian board for that mater) all want three things:

1) Pain to go down, Function to improve, lets call that womac observations coupled with PGIC
2) They want Structural improvement, reversing course of disease
3) They want the above two delivered in safe manner...




_{err...will there be anything else sir?}


PAR will need to sift through the data and discuss with the authorities and decide which dose to ultimately use (min effective dosing)...the ensuing discussions will assist here in determining the way forward...specially with any dmoad label adding connotations.