The first OA trial had two primary joint space width measurement endpoints -- one was a 12-month endpoint and one was a 24-month endpoint -- see link below. FDA requires sponsors to list the "primary completion date" as the date on which data is taken from the last enrolled patient on the first primary endpoint. That was done in August 2009 (as specified in the link below), so the trial is now over as to its first endpoint measurement (presumably the pain and function endpoints are each being measured at 12 and 24 months, as well, though this is not clearly specified). All this is by way of contrast to the second OA trial, which specifies only a 24-month measurement (hence the significantly later primary completion dates for that trial). In my opinion, what all of this means is that the DSMB and the clinical monitor now know what the results were on the 12-month primary endpoint for the 1st phase 3 trial. If the trial failed to reach statistical significance at 12 months, I am quite confident that Novartis would have declined to throw good money after bad, and that they would have followed a DSMB recommendation to abort this trial as well as the second OA trial. In other words, it seems highly likely to me that the data are looking good at this point. All of which makes it all the more imperative that this company sell off other assets to preserve common shareholders' interests in the royalties from the oral CT program. The last financing was an outrage -- let Novinsky and the board members know that you will sue them (just as shareholders did, successfully, in the Loral case) before you stand by and watch them take you to the cleaners with another outrageous financing.
A key date for me to understand these trials' progress is 9 December when Novartis is giving a general pipeline update to analysts (albeit with a special focus on oncology).
As diverse & impressive as Novartis' pipeline is, I fail to see how they won't spend time discussing a compound with potential for disease modification in osteoarthritis - i.e. not just symptom relief. The fact the first PIII is due to report in Q3 2010 should also attract attention on the day.
I don't believe see any "outrageous" financings looking forward. What I do see is a geometrically increasing revenue stream from B12. The benefits of B12 supplementation in energy levels, stamina, oxygenation- a general sense of well-being and vibrant health- are very well documented and widely accepted. But achieving bioavailability in oral administration has been the holy grail. We now have the grail in our hot little hands. There is NO question Life Extension Eligen B12 will be on the short list for supplement product of the year 2010. It will be a hot seller in a hot retail retail category and the possibilities are begging for action. What about Clif Bars, what about Special K? What about vitamin water. ANY PLACE you see vitamin b complex added to a food or nutritional supplement is a potential market for Eligen.