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Re: jq1234 post# 112531

Thursday, 01/13/2011 11:10:07 PM

Thursday, January 13, 2011 11:10:07 PM

Post# of 257268

That's exactly why you can't just listen to what the company says. Look at the data, what they said was not entirely true - they always exeggerate benefit minimize risk:


Quote:
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From TASKi2:

The mean increase in blood pressure from baseline at 6 months, using a last observation carry forward methodology, was less than 0.5 mmHg for the 150 mg qd dose group and approximately 1 mmHg for the 100 mg bid dose group. Approximately 18% and 23% of patients in the 150 mg qd and the 100 mg bid dose groups, respectively, had blood pressure medication adjusted or in some cases initiated during the course of the study, compared with 7% of the placebo patients. The blood pressure was successfully reduced in these patients, and their blood pressure was generally well controlled throughout the trial. The blood pressure medications were standard doses of common blood pressure medications such as ACE inhibitors or diuretics.

Placebo 150mg qd 100mg bid
Mean Blood Pressure(Systolic/Diastolic in mmHg) Baseline 125/76 125/77 125/77
At Month 6 123/76 125/77 125/78
Change from Baseline to Month 6 (LOCF) -1.8/+0.4 +0.2/+0.3 +0.6/+1.4

To be a little fair to RIGL, I wasn't exactly quoting them verbatim, but rather doing my best to recall what I'd heard in their presentation. It's probably not fair to say they indicated there was no longer a blood pressure increase past month one. I think the overall point was that blood pressure was generally controlled past one month. Given that they had said before that there was a 2-3 mm increase in blood pressure before in that first month, I don't think it's a huge leap to state that blood pressure is generally controlled when you go from a 2-3 mm increase at the end of the first month to a mean increase in blood pressure of either 0.5 mm or 1.0 mm at the end of 6 months. I.e., I think it's pretty fair to say that blood pressure is pretty well controlled once anti-hypertension medication is adjusted during that first month. I can't imagine that very small mean increase at the end of 6 months, even if that's consistent over time, is going to translate into a statistical difference in cardiovascular outcomes over the course of time, but I guess that is a risk. Given that I think the market is pretty much already pricing in failure for the drug, and I'm at least fairly confident that this won't turn out to be an issue, it's a risk I'm more than willing to take on.

Also, I think the market is pretty much entirely discounting the rest of RIGL's pipeline, which is kind of interesting to me (#msg-55725991). I'd be curious to hear any opinions you may have on the rest of their pipeline outside of the oral RA drug.

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