<<Nice looking results. Rather a muted reaction today - maybe we've already had our move related to these results. >>
Maybe, and maybe not!
That there was buy-on-rumor (note on early completion of the PIII trials) and sell-on-new mode, no doubt. Still, that many (or maybe few) figured out value of today news, I doubt.
Four very important peace from news:
1. The results of the primary efficacy analysis for the first trial indicated that ATTENADE was significantly more effective than placebo (p=0.0003) as evaluated by a behavioral scale (Teacher SNAP-ADHD), signifying an improvement in the clinical status of the children. The results of the second trial confirmed the drug's efficacy and duration of action.
2. The trial also demonstrated a statistically significant longer duration of action for ATTENADE versus dl-methylphenidate (p=0.015) as measured by a behavioral scale.
3. In both trials, behavioral and objective measures were examined. ATTENADE had improved scores over dl-methylphenidate in all parameters measured.
4.''Surprisingly in both multi-center studies, our initial hypothesis on the duration of action of ATTENADE based upon the Phase I/II study was confirmed,'' said James Swanson, Ph.D., professor of pediatrics, psychiatry, and social sciences at UC-Irvine. Dr. Swanson served as primary investigator of the studies.
So, what were investigators hypothesis and expectation, and why were they surprised that both study have good results? Maybe my next post with full PII results (from CELG patent) may explain today news better.
Summary: Improved score results and longer duration (in all doses is my reading)! What else we need?
Or, one should wait for presentation at Oct. conference and than value results.
Just to be clear, side effects profile is not that important here. Ritalin is well tolerated with very mild side effects. However, it does not work well for everyone and sometime larger dose and more frequent administration are necessary. And, drug performance improvement on this two point, rate response and response duration, is where ICE like ATTENADE will find its place on market.
Miljenko |
