Rigel Pharmaceuticals, Inc. (RIGL) Message Board

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Rigel Pharmaceuticals, Inc. (RIGL)

RIGL 31.58

-0.1%

Oct 31 9:30 AM EDT

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

To: tuck who wrote (520)	2/2/2011 8:36:35 AM
From: mcbio	of 566

The potential for there being a breast cancer signal with Syk inhibition is really the one big thing that I could see ending development of FosD. Peter backed off some of his initial concerns I believe by noting that the findings are more theoretical in nature and occurred in a knockout mouse model which certainly may not translate over to humans. I would think too that if the FDA had grave concerns over this, wouldn't they have already halted clinical trials of FosD? Or would they be comfortable in allowing the extensive Phase 3 trials to run through to completion but perhaps make monitoring for some type of cancer signal an endpoint in the trials? I'm guessing this type of analysis is not incorporated into the Phase 3 plans, because trials would likely have to be much bigger and longer duration to detect some type of breast cancer signal with FosD treatment. At the end of the day, presumably it's going to be the regulatory risk, assuming the FosD Phase 3 trials are successful, that is going to be the biggest concern with the question of whether or not the FDA comes back to AZN and does request extensive trials to rule out a breast cancer signal.

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next