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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (9424)	11/6/2003 8:19:06 AM
From: Michael Young	Respond to of 52153

<<5. No dose response relation, Opposite?>> That is the big red flag for me. I've noticed that a lack of a dose/response relation in these small Phase II trials leads to Phase III failure. MIKE

To: Miljenko Zuanic who wrote (9424)	11/6/2003 9:51:43 AM
From: Biomaven	Read Replies (1) \| Respond to of 52153

Some comments to Miljenko's analysis: 1. Severely compromised baseline placebo and drug groups characteristic (LDL and HDL baseline level and few other measurements). I will say that this was intentionally done by INVESTIGATORS, the same ones that asked for JAMA embargo. From what is known ApoA-IM does have effects on pts with LOW HDL level. Yes these were very sick patients - they had all recently had a serious coronary event. I don't see anything wrong with that - you wouldn't try a procedure like this on moderately sick patients. I strongly disagree that this was some sort of intentional skew of the study - the investigators are all highly respected doctors with no financial interest in the company. Agreed that the patients in the trial did not have particularly low HDL - I would assume you would see even more benefit if you selected for patients with low HDL. They couldn't do that under the terms of the study - they had to take their patients as they found them (assuming they met the entry criteria). 2. Second observation is NO CHANGE in coronary luminal diameter and lumen volume. Yes, this is interesting and discussed in the paper. It implies that the reduced atherosclerotic burden is taking place in the wall of the artery. Perhaps it is reflective of a decrease in arterial inflammation? (In mouse studies this treatment reduced the amount of cholesterol [and macrophages] in plaque, suggesting a stabilization of the plaque). Clinical impact is unclear, but my cardiologist friend did not see this as a negative. No argument with your third and fourth points. 5. No dose response relation, Opposite? This is confounded by the fact that the two groups had different baseline characteristics, with the lower dose group having a higher plaque burden. Need a bigger trial to really determine whether there is a dose-response. Peter