the PIII data......IMO this is a weakness of the data (one of many actually) so the PIII target was based on PII trial results and learnings, yet the PIII data failed to confirm the PII outcomes...this IMO creates a problem for TST as IMO the FDA desires confirmation of various trial outcomes...so if 40% was seen in PII and then used to design the PIII and that result was not achieved the FDA will appropriately ask why and then try to determine what does that mean...often it is the result of small cash starved baby biotechs running trials that are too small and so data is not reliable..
..who knows if this is the case here but IMO it weakens the case...on the counter is unmet need...and if approval granted it will come with a very signficant label restriction and a requirement for a PIV properly powered trial
...but of course the bagholders like arutherie (how do he spell that funny name) never seem to have looked closely at things, too busy bagholding and engaging in odd sexual deviencies at BNC's AGM...