Replies to post #47007 on Biotech Values

[iwfal]

It has lengthened progression-free survival on the label; for the reasons I’ve mentioned, this is tantamount to a QoL benefit.

Because it's "obvious"? Isn't it equally "obvious" that any drug with a TTP advantage ought to have a survival advantage - but many do not. Per the FDA's own documentation, TTP is a surrogate for survival. If QOL was what companies were aiming for they would test for it and wouldn't run the risk of failing on survival and being pulled.

Personally I think the trade of using TTP as a surrogate for survival in a long-time-til-death trial is fine, even if the correlation is only 50%. Just as a way to get a drug to market years faster. But to say a drug that makes you pretty sick is a QOL thing is a stretch - at best.

[p3analyze]

"I note that some of your assertions regarding Provenge and related topics strike me as delusional. For instance, you once posted that PGS and I were depriving DNDN of needed capital. My advice to you is to lose the emotionalism that seems to pervade some of your posts on this subject."

Wow good memory- I made that remark that you and PGS were short some time in 06 when DNDN suffered another secondary. Don't you have better things to care for?

Perhaps you could use this same advice while we are discussing the topic of Gemzar ovarian. Where in my previous post was I being irrational? I simply pointed out that you were wrong. I would even suggest you read the FDA endpoint guidance as well as CPMP points to consider on cancer endpoints. QOL is clearly listed as a separate endpoint, to demonstrate benefit, one needs to utilize validated qol instrument.

Maybe Lilly submitted ad-hoc data supporting qol benefit, but why is it such a secret that only FDA can see? Was it statistically significant, was the sample size large enough to make you "100% sure"- using Hussain's lingo?

The behind the closed-door decision making process of FDA reeks large pharma favoritism and double-standard conflict of interests. Lilly got away with negative OS data on two counts: Alimta NSCLC and Gemzar ovarian. Maybe what Pazdur is really saying is "OS is gold standard" only when he thinks it is.