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Biotech / Medical : Rigel Pharmaceuticals, Inc. (RIGL) -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (406)12/30/2008 12:21:58 PM
From: mcbio  Respond to of 566
 
Tuck,

Certainly not good news but, like you say, I think it means only that the drug would be contraindicated in pregnant women. I wouldn't think the FDA would halt trials or ultimately reject the drug based on this news. I hope I'm right in that assumption.



To: tuck who wrote (406)12/30/2008 1:38:28 PM
From: mcbio  Respond to of 566
 
I should also mention Accutane. The drug causes very serious birth defects but that did not stop the drug from being approved and a commercial success. I think one could argue that R788 targets a more dire patient population (RA, lymphoma, etc.) than does Accutane (acne) and therefore might be afforded even more leeway in terms of safety.



To: tuck who wrote (406)1/13/2009 2:28:05 PM
From: mcbio  Read Replies (1) | Respond to of 566
 
Tuck, I want to jump back to this with a few additional questions I probably should have asked before.

First, where did you find this information and in what context is it presented? I.e., is this something that is going in a major medical journal, data being presented to the FDA, etc.?

Second, I wonder if this is information that has been known for a long time or if this just became known. Given the recent date and no mention before that I can recall of these side effects, I assume it's recent.

Third, if recent, why wouldn't the FDA have already asked RIGL to amend their current ongoing trials for R788 to contraindicate for pregnant women or those about to become pregnant or otherwise halt the trials altogether?

Fourth, while I still believe the long-term prospects should be good, I could see the stock experiencing further weakness given this information. Any idea on whether or not the information you posted should be widely known at this point and already reflected in the stock price? This is why I asked about where you obtained your information and the context in which it is presented.

Finally, why is there a reference to "R406" in the article you posted? Most of the references in that article are in fact to R788, but towards the middle there is a reference to an "R406."