DDXS will immediately get a tripling or quadrupling in share price if Glaxo is correct in their belief that Darapladib reduces or delays the onset of cardiac events in healthy and unhealthy adults:
1) following a failed phase II trial, Glaxo spent close to 1.5 billion dollars enrolling and administering drug to about 27,000 human volunteers in a 5 year study. This is clearly a sign that they believed the dollars and time spent were worth the risk.
2) pharmacokinetic interaction study beginning now, doubt they do this without some indication it is needed. Why not wait til the results are in hand-unless they are...
3)Glaxo spent 3.2 billion dollars to acquire HGSI for the remaining 20% rights to Darapladib. It's clear now that there was no other reason for the HGSI acquisition. Benlysta is now Bustlysta.
4) Every few years a major breakthrough or advance comes along---(this is our luck factor).
DDXS is worth $1+ without Darapladib. With Darap, at least a triple. Is it worth speculating whether Glaxo has any insight into the data? I get it. They are certainly acting and preparing like it is going to work. They are betting that it is going to work. But do they know anything that makes the odds better than what is generally expected. Most pundits give Darap less than 50-50. Glaxo is acting like 80-20.
In 2008 before the stability trial started, the relationship of lp-pla2, LDL, high density lipoprotein, and stroke wasn’t fully understood according to Dr. Myers of CDC. In fact, there was concern that the BENEFITS of lp-pla2 might outweigh the negatives. This was the only real concern and a week one at that. 80% of lp-pla2 is carried by LDL, the other 20% associated with HDL. In mice, however, almost all Lp-PLA2 is attached to HDL, and mice don’t get atherosclerosis.
Thus the concern was that you might need lp-pla2 attached to HDL like mice to be protected and the reduction of Lp-Pla2 with darapladib might cause more harm than good.
It stands to reason that if darapladib and its reduction of Lp-pla2 was increasing risk for harm, the study would have ended prematurely instead of being delayed a few times. Just the opposite has been demonstrated with the effect on troponin levels on patients with acs which shows that risk has been reduced. Risk 101 tells us that when you reduce risk broadly against large numbers, you will reduce the severity and incidence of unfavorable outcomes. This is exactly what Stability will show and why GSK is acting like its 80/20.
I see you are here since the Vaxgen days... What a long ride for you! Hope it plays it for all of us.
I think that these big companies get wind of the trial way before the results are out. Investigators are talking all the time and with an event driven trial----time to first cardiac event, I think that doctors observing patients have a pretty good idea if sick patients are hanging around longer then normal(sounds pretty morbid).