Biotech Values

[DewDiligence]

From ICPT’s 10-K (page 14):

http://www.sec.gov/Archives/edgar/data/1270073/000114420414015854/v371132_10k.htm

We recently received a report of blinded FLINT safety data from the NIDDK and have learned that as of the end of December 2013 a total of ten cardiovascular serious adverse events had occurred in seven (2.5%) of the patients in FLINT across both treatment groups, at which point 207 (73%) patients had completed the 72-week treatment phase and 73 remaining patients had all been on study for 60 weeks or more. As part of its review, the trial’s DSMB expressed concern regarding hyperlipidemia and the occurrence of serious cardiovascular events, both of which were seen in both the treatment and placebo groups, but disproportionately in patients receiving OCA. However, the NIDDK has advised us that while the incidence of the serious cardiovascular events was numerically higher in the patients receiving OCA therapy, it was not statistically significantly different as compared to the placebo group.

It’s generally a bearish sign when a biotech company dismisses a kind of SAE because it wasn’t statsig more frequent on drug than on placebo.