| | | Several of the posts regarding timing of eprat results with links to the UCB site caused me to look into their Phase 3 trial for brivaracetam for epilepsy. What we seemed to have learned over the last week or so is that UCB will not be bound by arbitrary timing. What I believe we have known all along is their meticulous approach to drug trials. As noted by kdd they spent considerable time analyzing the brivaracetam results. Their published findings reflect that effort. The p values showing statistical significance were less than 0.001. The studies were completed in May of 2014. Results were released in July, and regulatory filing in both the US and Europe did not occur until January of 2015.
The eprat trials have taken far longer than most of us had hoped. Every step of the way seemed to drag on. But, in the end it may pay off for UCB, IMMU and stockholders for both companies. I did a cursory search to try to find UCB drug trial failures. I did not find anything off the bat. More persistent searchers on this board may be more successful. What I did find was articles and papers generally on the subject of Phase 3 trial successes and failures. Over a period of years the overall success rates have declined from about 70% to a range of 50% to 65% [pick your source of data]. The reasons for failure are mostly attributed to inadequate Phase 2 trials particularly with respect to efficacy and safety. Most of us seem to agree that UCB spent a long time on the Phase 2 trials, which yielded data sufficiently compelling for them to invest in Phase 3 trials. UCB's market cap is $12.4B - about 1/10th of players like AMGN, AZN or GSK. Thus, they are motivated to reduce the risk of failure as much as possible. And, they have a reputation for that.
So, we wait! But, the good news is that our wait has nothing to do with IMMU. Frankly, I ignore the IMMU bashers in this case, because, again, it is nothing about IMMU. And, sadly, for the option holders UCB probably does not pay attention to IMMU options. If results are successful, the ultimate wait may be quite a bit longer. |
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