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

To: Mudcat who wrote (26743)	12/3/1998 3:16:00 PM
From: celeryroot.com	Read Replies (1) \| Respond to of 32384

Mudcat, why do you keep saying the fda is giving Ligand a hard time? What they are doing is following the precedures. In the case of Panetran, it was reviewed within 6 months. This is not the norm. It is usually 1 year. They are not giving Ligand hard time as you state. I suggest if you want to no what the FDA giving someone a hard time is all about go check Chir/Ceph on myotropin.

To: Mudcat who wrote (26743)	12/3/1998 4:53:00 PM
From: Henry Niman	Read Replies (2) \| Respond to of 32384

I said approval would be a slam dunk for Panretin. The FDA issued an approvable letter 9 days after the Panretin advisory committee meeting and LGND (and analysts) are projecting approval this month. Why do you think the FDA is giving LGND a hard time? Do you think that ONTAK and Panretin will NOT be approved? The combined rec votes were 20-1 for approval (which I would put into the slam dunk category).

To: Mudcat who wrote (26743)	12/5/1998 10:10:00 PM
From: LLCF	Read Replies (1) \| Respond to of 32384

<The Times reported that the FDA has been extremely lenient in approving drugs lately.> <What would the delays be like if the FDA was actually following their own procedures (by the book)in approving Lgnd products.> The fact is that the FDA is changing (albeit slowly), their whole way of looking at the process. What you're talking about IS by the book now... they're NOT going back. <Many of the approvers in a survey said that they have been approving drugs that really should not have been approved.> Any what exactly does this mean... does the NY Times talk about that? Looks to me that they are quoting the (liberal) Citizens Action Committee on a lot of this stuff. Does it mean the drugs are dangerous? That the drugs arent very effective? That they don't work at all? Do you realize that in Japan all you have to really do is prove the drug won't hurt anyone [Phase 1 here]? That article may have been very misleading. If anything they'll get some more people on their staff and quite dragging their feet like all these government agencys do... you know they throw that stuff in a pile and say "great, we have 6 months on that one from today. Let me put it on my calander for April! Now, off to dunkin doghnuts." DAK