Biotech / Medical | Cell Therapeutics (CTIC)


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To: former_pgs who wrote (559)3/7/2005 5:28:50 PM
From: zeta1961   of 946
 
<If it was up to me I'd let the clinics decide the cost / benefit trade-off that is appropriate.>>

They already do..a cursory look at recent actual sales of onc products an example..MOGN last I heard has been constantly revising Aloxi figures based on uptake that the analysts who make these projections could not predict..or could have if they'd spoken to people in the trenches<g>


<<However, for CTIC the stock, the plight of patients is not always sufficient to get the various agencies moving in the ways that we would like them to.>>

Lost you there..but I think I get your overall point..my point is that alopecia is a side effect that is underappreciated as an issue and imo, would be a deal breaker even if everything else was equal..herds who make a living playing good and bad PR's could care less today..but those who have to make treatment option decisions are looking at these results from a different perspective


The ASCO meetings should provide more insight about all this..

Zeta

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To: zeta1961 who wrote (562)3/7/2005 6:06:09 PM
From: rkrw   of 946
 
Did they say how much less alopecia the xyvotox had?

I once knew someone that had alopecia, woke up one day with no hair on his entire body. He used to peel off his empty beer bottle labels and stick them on his head. Talk about taking the alopecia in stride!

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To: zeta1961 who wrote (562)3/7/2005 6:06:27 PM
From: Sam Citron   of 946
 
alopecia is a side effect that is underappreciated as an issue and imo, would be a deal breaker even if everything else was equal

Why is this issue a "dealbreaker"?

And what is the solution to the mystery of why both arms of the study apparently survived substantially longer than expected [most had assumed it was just the Xyotax arm]?

Sam

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To: Sam Citron who wrote (564)3/7/2005 6:20:45 PM
From: zeta1961   of 946
 

Why is this issue a "dealbreaker"?

Sam this is part of a dialogue former_pgs and I have been having which was based on below statement about his opinion of Xyotax uptake and alopecia

As it stands, paying extra for a taxol equivalent without hair loss many not be an economically compelling option.[by former_pgs]

Sam, regarding the survival mystery: haven't had the time to listen to the CC yet..

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To: DewDiligence_on_SI who wrote (561)3/7/2005 6:38:22 PM
From: Biomaven   of 946
 
I don't understand how the Cox regression can be highly stat sig when the Log isn't.

That can easily happen if the two arms turn out not to be balanced. The Log test assumes the two arms are identical. The Cox doesn't. The key is if all the factors in the Cox were indeed prespecified.

Peter

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From: Rudy Saucillo3/7/2005 7:30:11 PM
   of 946
 
Sounds like, from the cc this morning, that Bianco and co. at least believe they understand what went wrong with the trial...and will report at ASCO.

Irrespective of these risk factors that confounded the log rank analysis, I simply can't imagine the control arm performing as it did.

STELLAR 2 reports next. Correct me if I'm wrong...isn't this an all U.S. trial??? From the clinical trials database, I see no stratification based on geographic location and no treatment sites outside of the U.S. (i.e., no Canadian sites).

So, if the issue had to do with limited control of international sites, we may not see similar issues in STELLAR 2(?)

Re. the proposed revision to the SPA, my guess is that the FDA will be agreeable to it.

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To: zeta1961 who wrote (565)3/7/2005 8:27:54 PM
From: Sam Citron   of 946
 
Zeta,

I didn't mean to interrupt your conversation with former_pgs, but was interested in what you had to say about this frequent side-effect of cancer treatment. I know very little about alopecia, but am sure it something that a cancer patient must feel very deeply as a sign of loss of the patient's healthy self. In a younger patient (probably not relavent to Stellar 3 population) it must be particularly devastating. Economists tend to be obsessed with quantification: e.g., is it treatable and if so how much is spent to treat it; how much is spent on wigs to disguise it, etc. I know it is impossible to quantify everything, but also know that only by trying to do so can we get even vaguely accurately cost-benefit analysis that is so important in the public policy arena. Your use of the "dealbreaker" word surprised me, and I was just hoping that you could educate me a bit on it. Perhaps it is one of the key factors that needs to be better understood to appreciate the value of Xyotax.

BTW, is alopecia the result of the radiation treatments or the drugs used in conjunction with them? [shows how little I know]

Sam

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To: Biomaven who wrote (566)3/7/2005 8:51:52 PM
From: DewDiligence_on_SI   of 946
 
>>That can easily happen if the two arms turn out not to be balanced. The Log test assumes the two arms are identical. The Cox doesn't. The key is if all the factors in the Cox were indeed prespecified<<

[The italicized text comes from msg #558 by Ian Stromberg]

It was Bianco’s incessant talk about these multivariate analyses --rather than the underlying mathematics per se— that constituted what I consider “spin” on the CC.

My take on the “non-inferiority” issue (FWIW):

investorshub.com 

Regards, Dew

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To: Sam Citron who wrote (568)3/7/2005 9:26:11 PM
From: zeta1961   of 946
 
Sam, sorry for any confusion..by deal breaker I was saying that if Xyotax indeed shows equivalent efficacy to taxol..I'll even venture to extend that now to: if absolutely everything about the two agents is equal(efficacy, side effects) the fact that it's given in just 10 minutes(huge)...it protects the hair follicles, avoiding alopecia, it's my opinion that oncologists and patients would choose Xyotax..

Hair loss is a HUGE psychologic issue with cancer patients..young and believe it or not older patients also and most especially with women of all ages(remember that taxol(including its generics but too lazy to spell out paclitaxel!) is used in breast cancer, ovarian in addition to lung..

I do some oncology consulting on the side and just recently received an update from a 70ish year old woman..second to telling us how pleased she is with the cancer's regression, it was her hair growing back that she expressed satisfaction..


These days in oncology, as you know, there is a real push for QOL considerations as evidenced by Alimta's approval eventhough it did not show a survival benefit, these targeted molecules like gleevec, tarceva etc..

In answer to your second question, alopecia is a result of each radiation and chemo separately..the poor folk who have to have radiation and chemo for anything in the head and neck region(throat, esophogeal, brain) get doubly inflicted..in many cases their hair regrowth is limited as a result of the direct and double 'hit'...

Besides the body appearance issue, these patients have to use extra care in protecting their heads from the natural elements like sun, heat, cold..we have kept our hair during our evolution for good reasons<g>..

As rkrw pointed, many take this in stride, try to make light of it("my shampoo costs are down")but it's something they'd gladly not have to deal with..wigs(good ones) are costly, hats after a while get costly..sure, it's a trifle concern compared to survival but if there's something as effective without this effect..the answer seems obvious to them and their oncologists..

Was that more clear?..let me know..

Lastly, Wick, the CEO of TELK also pointed to the issue of alopecia with the women in their ovarian cancer trials at JPMorgan in January..to paraphrase:[when speaking with clinians and patients, we found out how much alopecia is a concern..based on my experience, I had no reason to question the validity of his claim even if it was for his marketing presentation..

Zeta

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To: former_pgs who wrote (546)3/7/2005 10:08:55 PM
From: DewDiligence_on_SI   of 946
 
>>I bring up economics because paclitaxel is generic. Although CTIC did not really discuss pricing that I'm aware of, I think it is a safe assumption that Xyotax was going to be priced competitively against branded products rather than competitively against generics.<<

It’s refreshing to see someone address the pricing issue. There have been so many posts about whether Xyotax is still approvable and hardly any about whether it will still be able to be a commercial success.

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