Well, nothing in the preamble gets me worried that thorough QTc prolongation studies would go away. If someone actually buys the report and can provide it somewhere publicly, I'd be happy to read it and comment. Actually it sounds a little like pharmas are worried a mild prolongation of QTc could nix a promising drug even though the QTc studies are at higher concentration of drug in the body than therapeutic doses or that a negative QTc study could allow a drug through which may have concerns based on other studies. Again doesn't imply that QTc studies would go away. I congratulate you on being a short who provides a meaningful reason for supporting your position other than "this is a POS". Others take note!
Following was included in his hotline dated today.
I received a subscriber question from Ed about eResearch Technology (NASDAQ: ERES) about a paper regarding the draft regulations for QT trials to be considered at the ICH meeting in mid-May. Ed, I bought the paper for $50. All he is saying is that in addition to the QT studies there are other studies that should be done to confirm or not miss a real problem. I don't see how this would affect eResearch Technology significantly.
There seems to be one potassium channel in particular that a drug could interfere with to cause prolonged QT in human heart cells. Among the non clinical studies that could be done first include studying the effect of the drug on individual heart cells or studying the effect of the drug in rabbits or dogs first. If these studies were non concerning, then clinical trials in humans would still have to be done later in the process. It may be that clinical trials in humans would not be done as the first studies to identify prolongation of the QT interval. This would have some negative impact on revenue for ERES but to what extent, I don't know. Clinical trials definiteley would not be going away. I can't imagine, nor have I seen, anyone proposing this.