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Re: DewDiligence post# 136704

Wednesday, 02/08/2012 10:27:53 PM

Wednesday, February 08, 2012 10:27:53 PM

Post# of 251562

Reuters chimes in on Xgeva vote; odd quote from the patient rep on the panel:

www.xe.com/news/2012/02/08/2459393.htm



Interesting you singled this particular comment out, as I understand that urologist representation on the panel was zero. A little disappointing that clinicians that treat these patients were not represented well on the panel. I understand the criticisms, heck I thought the ONJ issue was mostly resolved with careful selection of patients who didn't need extensive dental work? I thought the rates of ONJ were much lower in previous trial experiences with D-Mab? I agree that 5-7% rate occurance in asymptamatic patients is pretty troubling though.(not that this was the only criticism, valid or not) I think the only XGEVA vote had a point to a degree, although I think he/she exaggerated a bit. I think we have probably beaten the ADT therapy pathway to death, and probably/maybe detrimental. I think new MOA's are starting to get more attention/research, and new research ADT's may be slowing, and combinations with other MOA's is probably where this is heading.

Very disappointing for Exelixis. I assumed that an XGEVA failure would discourage Exelixis from 308 trial. The conference call statement about 308 being a low priority confirms my thoughts.(Exelixis management didn't seem too interested in talking about the XGEVA events or 308 for that matter, and likely represents the death of planned 308 trial) I don't agree that this is a neutral event for them. Exelixis is already gun shy after SPA incident. I understand Exelixis has limited financial resources, but they need to trust their drug to some degree, and take some shots down the field. These dump off passes down the field could eventually be detrimental for Exelixis. A competitor will eventually pick them off, and take the risk going after these larger markets, while exelixis will be messing around in other phase 2 salvage stage cancer indications. Although a competitive drug isn't in sight, I would guess biotech isn't standing still.

I am starting to believe what others have stated that Exelixis is preparing for a buyout.

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