"Have worked a bit at one point in my career on some immunology-related projects, and have spent enough time working with statistics, and analyses of complicated data sets, and long-term data sets, to understand how studies like this work, and how the experiments need to be set up, and what needs to be done with the data in the end. "
So, you understand how to design experiments to test hypotheses.
Doesn't it bother you at all that CVM has not performed any experiments to test the hypothesis that Multikine, an amalgam of IL-2 and other cyto-/chemokines, is different than IL-2 alone? Never has CVM published anything on this topic, yet that hypothesis is central to Multikine. Astonishing lack of competence or simply deceitful?
Doesn't it bother you that CVM never did run a real clinical proof-of-principle trial with Multikne, despite geert's protestations, just that Hungarian path trial that Geert attempts to force 'outcomes' analysis oin -- completely illegitimately -- after the fact?
CVM's actions betry what it is -- a vehicle to enrich its principles under the guise of a drug developer, but drug development is only a guise!
Years and years of the same. Draw another card, go fish.
Hey dopey PSI ... This will never hit $3.10 BEFORE word on PIII progress or HPV results. I am selling what LITTLE I have left tomorrow morning and then will LEAVE this foul board forever.
Sentiment: Strong Sell
Sorry yankeepoo, didn't mean to rain on your parade... But, facts are facts, sonny..!
Sentiment... Oh Lord, I feel another empty novel in the works...
Sentiment: Strong Sell
as an adjunct they have a very good chance of identifying sub sets that these proteins activate
Dear David. Didn't want the ole pap to be the one to tell ya this, but I think Kathy wants to move in with me and "MIDNIGHT". Not because she's impressed with our bus, but because she told me you come up short, if you get my drift.
Sentiment: That Kathy's a REAL screamer, but I just wish she'd stop pushing my beach bunnies outta da pap's bed.
His caps lock is stuck just like "dr_tjobe09"s was........................hmmmmm
Yank, there is no possibilty for accelerated approval for Multikine.
You see, Yank, the FDA has to agree that a study using a surrogate endpoint (tumor shrinkage or PFS instead of survival in cancer, for instance) can qualify for the program, or it can decide to apply accelerated approval after the fact if the data from the completed study using a surrogate endpoint are particularly promising.
FDA has signed off on a survival trial for Multikine only, this garbage has no real clinical outcomes data from the joke that Geert calls PhII to review so all of that will come from the current trial when it finishes anyway, making accelerated approval, much like your mental faculties, a complete non starter.
Gee, what an investment opportunity!
But wait, some see salvation in --- anal warts and HIV/HPV co-infections! Filthy lucre indeed!
What a joke of a company!
The Reuters article was originally posted on 7/25/13.
I will try to post a working link asap.
Sentiment: Strong Buy
Geert once promised that the PhIII enrollment would be completed in 15-18 months.
The new timeline for completion of enrollment is the latter part of 2015.
The trial kicked off in December 2010.
What a complete joke!
I've seen that phrase used before too yankee - but don't know of any drug that has recieved that accelerated pathway. That doesn't mean that it hasn't happened, just that I haven't seen it.
You know of any cases where this has been applied? 'Cause if tumor shrinkage turns out to be an acceptable proxy measure for anti-cancer use of Multikine - that could move our endpoint up a year or two. That is (of course) assuming that tumors can be clearly demonstrated to shrink during the early parts of the Phase III data assessment.
Some efficacy in tumor shrinkage - coupled with apparently low toxicitiy - could get us a kick-start.
hey dk.... This has been posted before: "Under a separate pathway known as "accelerated approval" drugs may be approved based on a so-called surrogate endpoint - a measure, such as TUMOR SHRINKAGE - that might reasonably be expected to confer a clinical benefit such as improved SURVIVAL."
Sentiment: Strong Buy
Sadly - that sounds about where I was expecting it to come out now. If they manage to fill the study dring 2014 (hey - it could happen) they need the treatment time completed (the Dec. 2015 date), and the follow-up time to assess cancer re-occurance (the Dec. 2017 date) to run their courses.
Definately a 'YUCK!'
That's why we should all be sitting on the sidelines (for now anyway) at least until we can see how the HPV work is going. That shouldn't take as long to get underway, or completed.
"Shouldn't" being the operative word.
Yank Me I poop on you. I'm not Adam, I'm much better looking.