Sorry friends but i have two questions.. i listened and listened again the conference but my english is shaky. Proel said something about the damages but i did not understand if they are low or high.. 250/350 is a mountain of money. At the end he said also something about Uceris and the reasons for the delay.. what are these reasons? I think they are related with study population and good practices but i'm not sure.
mossa, He didn't say how much the damages might be, only that they hoped for damages due to lost profits and not treble damages.
For Uceris, some patients and sites were dropped from studies for various reasons (this happens in most trials). Said that all the data was in the 1st package to FDA, but another division has to do a report on GLP (sites excluded for Good Lab Practice violations). They (the other division does an audit of some good sites and some sites in violation, to see if it matches what SNTS reported). The sites are mainly in the EU and India, need time to visit them etc). Since the new division needed to review the data, they needed more time to investigate and report on findings (Oct 16 PDUFA didn't give them enough time). Launch is still for Feb (so, no real delay because of winter holidays), if approved by Jan 16 PDUFA.
I looked at the slide deck from Sept 5 Stiefel Nic. meeting and at the bottom it says how many were excluded in EU and US. The sample sizes (n) and p values for the slides from Sept 5 are identical to the Piper one I had saved from Nov. 2010. So the data is the same and FDA are aware of it (this is the entire data they accepted for PDUFA review) and FDA has been working with SNTS every step of the way. Minor glitch IMO. He also talked about the reasons for the Dutch shootdown (ie comparing efficacy numbers for something like Lialda, but not taking into account the low placebo value for the Uceris study). Also, said Uceris had different inclusion criteria. Hope this helps and makes it more clear. In other words Dutch didn't look at the ratios of % efficacy/placebo. Lialda had higher efficacy, but also a much higher placebo response. IMO the Dutch ignore statistical relevance, where the FDA should not. GL