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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?


To: Henry Niman who wrote (18521)4/2/1998 2:21:00 PM
From: WTDEC  Read Replies (1) | Respond to of 32384
 
"Targretin Capsules have been
reasonably well-tolerated in the study population"

Henry, I'm a bit puzzled by the words 'reasonably well-tolerated'. It sounds subjective and, I think you would agree, reasonable people can disagree in such cases. Is this a weakness which could lead to rejection by the FDA? NDAs have been turned down for seemingly minor side effect issues.

"elevated triglycerides, a complication seen in retinoid therapies of others"

Do you know if there is any data as to the degree of elevation in the others, how that compares to Targretin or at what level triglyceride elevation becomes a problem from the FDA's perspective?

Regards,

Walter



To: Henry Niman who wrote (18521)4/2/1998 2:30:00 PM
From: tuck  Read Replies (1) | Respond to of 32384
 
Henry,

Thanks for that info. I now remember the debate over the wording of that press release. Was the protocol for the European trial ever made public?

At least my source has the TG info right. I must say, though, that since the doses are likely lower for diabetics in which such a spike is bad, then the spike would probably not occur in those cases. Thus if the spike is my source's only "major" concern about Ligand's retinoids, we should feel pretty good about them. Only folks with cancer and diabetes, a small population, might have a problem with it.

So let's see if I've got this right. Retinoids could both elevate (per the cited press release) and lower (per the mouse data Henry posted a short while ago) TG levels. I gather it is all dose dependent and that there are two different mechanisms at work.

Tuck