re: TELK
They were hammered on this in the breakout at JPM in January. They won't come out and say exactly how they've done it, but it is clearly:
(1) They will hold the data themselves until they have all three
(2) They have instructed the CRO to not do the analyses until all three triggers are hit.
The first is flat out wrong. The second is questionable and very problematic from a statistical standpoint unless their SAP with the FDA says something like "open the database when at least XXX patients" have had the event. Most SAP's I've read specify a specific number. (Others here can chime in if the SAPs they've done/read are different from my experience.)
PLEASE, PLEASE, PLEASE take what happened to CTIC investors as a caution against believing "longer is better." Even CTI management was saying that on conference calls and the only prospective statistically significant positive conclusion you can gain from those trials is you should go to Russia to be treated if you have lung cancer.
Unless otherwise indicated, this is the personal viewpoint of David Miller and not necessarily that of Biotech Stock Research, LLC
