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Old 09-26-2008, 08:29 AM #21
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Originally Posted by Av8rgirl View Post
...I listened to the conference call on the Opexa site last night and found a lot of the information very good. They focused on the annualized relapse rate of the Tovaxin group with the higher lesion load vs the annualized relapse rate in the place placebo group with a much lighter lesion load and the stats were put in a better perspective. The Tovaxin group had a might higher disability rate to overcome and it just happened to be coincidence. So, I am focusing on that and not some hocus pocus that these investors/non-trial participants are saying. These are the people I want (maybe others too) want to shoot. But that's me.

I know how *I* am doing so we shall see what happens. Moving forward, thinking positive.

Thanks for all the support everyone. It's been a rough year and a half.
LOL @ wanting to shoot the naysayers!
I listened to the conference call too, and I found a lot of positives in the data. Let's hope you get the news soon and that you make those MRTCs this time!
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Old 09-26-2008, 09:24 AM #22
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From what I understand so far about the trial, the results were viewed as not nearly as positive (as some people might have expected) in terms of relapse rates. They "expected" the Placebo arm to have annual relapse rates somewhere around .8 (similar to the initial CRAB trials):

Quote:
"Copaxone phase III trial: The final 2-year relapse rate was 1.19 for Copaxone patients and 1.68 for those receiving placebo, a 29% reduction. (1 - (1.19/1.68) * 100 = 29%)

Rebif PRISMS phase III trial: Average number of relapses per patient 1.73 for high-dose Rebif vs 2.56 for placebo, a 32.5% reduction (1 - (1.73/2.56) * 100 = 32.5%)

Betaseron phase III trial: The annual exacerbation rate for patients receiving placebo was 1.27 and for high-dose Betaseron 0.84 after 2 years, a 34% reduction (1 - (0.84/1.27) * 100 = 34%)"
... however the placebo group in this trial had an annualized relapse rate of only .334. ie. Even though Tovaxin still proved to reduce relapse rates to .21 vs .334 for placebo (a reduction of about 50% over Placebo) . . . because they were "expecting" a .8 Placebo rate (similar to the CRABs), it made this treatment "appear" not as effective as it probably is.

I think they should at least be able to take an "average" from the other trials, as obviously something went wrong here.

From what I gathered of the conference call, they think this happened because although everyone from both arms had a similar relapse history . . . they inadvertantly put the people with the most disease activity (number of active lesions at the start of the trial) in the treatment arm of the trial, and the one's with the least in the Placebo arm.

Seems like perhaps a silly mistake to make, but if it's true (or they had instead mistakingly put the "active disease participants" in the placebo arm), we certainly would have "appeared" to get entirely different results.

(Not that I think relapse rates are the end-all, be-all for evaluating the efficacy of these drugs anyway, but it is one of the current secondary measures . . . )

Cherie
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Old 09-26-2008, 10:33 AM #23
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I know who HE is, Cheryl... I went over there and read a bit and laughed my head off. Don't let any big mouth know it all, know nothings, P you O. Certain tranparency and stupidity loom large, in certain places, by certain people..

Good for you for keeping your cool...you're a better person for it.
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Old 09-26-2008, 12:35 PM #24
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Quote:
Originally Posted by lady_express_44 View Post
From what I understand so far about the trial, the results were viewed as not nearly as positive (as some people might have expected) in terms of relapse rates. They "expected" the Placebo arm to have annual relapse rates somewhere around .8 (similar to the initial CRAB trials):



... however the placebo group in this trial had an annualized relapse rate of only .334. ie. Even though Tovaxin still proved to reduce relapse rates to .21 vs .334 for placebo (a reduction of about 50% over Placebo) . . . because they were "expecting" a .8 Placebo rate (similar to the CRABs), it made this treatment "appear" not as effective as it probably is.

I think they should at least be able to take an "average" from the other trials, as obviously something went wrong here.

From what I gathered of the conference call, they think this happened because although everyone from both arms had a similar relapse history . . . they inadvertantly put the people with the most disease activity (number of active lesions at the start of the trial) in the treatment arm of the trial, and the one's with the least in the Placebo arm.

Seems like perhaps a silly mistake to make, but if it's true (or they had instead mistakingly put the "active disease participants" in the placebo arm), we certainly would have "appeared" to get entirely different results.

(Not that I think relapse rates are the end-all, be-all for evaluating the efficacy of these drugs anyway, but it is one of the current secondary measures . . . )

Cherie
The bottom line is that the trial was too small.
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Old 09-26-2008, 09:54 PM #25
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Ok....what?

I have to go back and read this again.

Give me time here.....
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Old 09-26-2008, 09:56 PM #26
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I've heard that many of the trial patients have been unblinded today. I never got a call....

Cherie, have you heard from Sweetyhide???
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Old 09-27-2008, 05:36 AM #27
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Quote:
Originally Posted by Av8rgirl View Post
I've heard that many of the trial patients have been unblinded today. I never got a call....

Cherie, have you heard from Sweetyhide???
I've "seen" her around, but she's in a very bad way at the moment and not talking the last few days.

Cherie
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Old 09-27-2008, 01:05 PM #28
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Quote:
Originally Posted by lady_express_44 View Post
I've "seen" her around, but she's in a very bad way at the moment and not talking the last few days.

Cherie
I am sorry to hear that. I know there is some "bickering" at the other forum and I hope that isn't adding to her stress. It's stupid what's going on.

I've not heard from my site coordinator, I guess the unblinding results are slow moving West

Ohio, Kentucky and Alabama people have checked in that they've heard. Oh well, whatever!
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Old 09-29-2008, 01:47 PM #29
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Quote:
Originally Posted by Av8rgirl View Post
I am sorry to hear that. I know there is some "bickering" at the other forum and I hope that isn't adding to her stress. It's stupid what's going on.

I've not heard from my site coordinator, I guess the unblinding results are slow moving West

Ohio, Kentucky and Alabama people have checked in that they've heard. Oh well, whatever!
Amen to the stupid stuff!
But my issues are un-ms-related - for a change!

Cheryl I called my coordinator and told her to find out. She did and called me back. I was on the placebo. Yes I did remarkably well - overall.
Glad of that.

edited to add:
Just got a call from my coordinator and they dont have to reschedule me (because of storm).
My vaccine is made and I get it tomorrow!

I am sticking to Tovaxin as long as they will have me.
My faith in my decision hasn't changed.

Good luck to you too!
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Last edited by Sweetyhide; 09-29-2008 at 02:02 PM. Reason: more info
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Old 09-29-2008, 10:09 PM #30
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Quote:
Originally Posted by Sweetyhide View Post
Amen to the stupid stuff!
But my issues are un-ms-related - for a change!

Cheryl I called my coordinator and told her to find out. She did and called me back. I was on the placebo. Yes I did remarkably well - overall.
Glad of that.

edited to add:
Just got a call from my coordinator and they dont have to reschedule me (because of storm).
My vaccine is made and I get it tomorrow!

I am sticking to Tovaxin as long as they will have me.
My faith in my decision hasn't changed.

Good luck to you too!
I called today and left an email but I never heard anything back.

I am glad you are sticking with the trial. I will too, if I get back in! I am waiting for the results of the last MRTC blood draw.
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