Yes, 112 patients, double blinded, so approx 56 each arm.Yeah in...

Yes, 112 patients, double blinded, so approx 56 each arm.


Yeah in hindsight it was a burdensome amount of resources to do the lower doses in 002 (stage 1)...but of course at the time it seemed like a good idea to test it out...a few did say why aren't we having a 2x2 arm to compare, but it was prob thought that we already have that data in a well controlled trial, why burn up even more cash to replicate the results?. This is also what gives me the confidence that the FDA shouldn't at all have a problem with the 2x2 as they themselves insisted that we try out a lower dose regime first. We did what they wanted, we should be able to move on now.

The real question is that we now have 2x2 in our 008 (and in our 005)...this data was off the charts...the benefits and observations in terms of pain and function and safety were clear cut against placebo but what about the DM connotations, the secondaries... all in a well controlled multi centred trial setting.... this should count for something.


It's quiet up above the water line, what indeed is brewing under the surface?








---- Examples of active -v- placebo in 005 and 008 programs:

005






008









Ref
1 https://app.sharelinktechnologies.com/announcement/asx/32c48c1b6e394b137d0897c29353e00c
2 https://app.sharelinktechnologies.com/announcement/asx/63a249bdb0b4e5e1dc93c8ee2644f3a2
3 https://app.sharelinktechnologies.com/announcement/asx/76393c2170325bd8cd425f9c4d0ffaae