This Is MS Multiple Sclerosis Knowledge & Support Community

Lars wrote:Hey All,
I'm bit confused, are we talking about the 11b trial? I'm not sure how the data could possibly be available by then.

Hi Lars,
I'm looking forward to seeing information as much as anyone but this release of interim data is pretty new to me.

I'm not sure what this interim data would encompass and I'm not sure the FDA would find it Kosher for anyone to root around in blinded data until the IIb is over.....but then again, I'm old and senile and not sure about a lot of things

If anyone runs across an official statement from Opexa talking about a planned release date for interim data, please share.

Bob

This article has been posted on this site already;

http://www.genengnews.com/news/bnitem.a ... e=17568660


Here is a relevant part of the article:

“David McWilliams, president and chief executive officer of Opexa Therapeutics, stated, "Full enrollment in this Phase IIb study is an important milestone in the commercialization of Tovaxin. With this milestone achieved, we now look forward to reporting a descriptive analysis in the fourth quarter of 2007 and the full data results in the second half of 2008."

Flipflopper,
Ask and ye shall..... Thanks for the post, that make sense.
Lars

Good work flipflopper, I'm impressed!! Seriously!

Trying to admit that I'm wrong chokes me up so hopefully "I stand corrected" is good enough

Bob

My neuro said that the FDA reviews the interim data to make sure that things are going okay. For example, if people on the drug were doing WORSE than those on placebo, they would end the trial immediatley. It makes sense that they would want to review that sort of data ASAP.

Have we come to any consensus as to November or September? I'd like to place my bet on October, just to be contrary.

Heather

akaheather wrote:It makes sense that they would want to review that sort of data ASAP.

That's true, but with that in mind, maybe Opexa won't/can't publicly post that info until the trial is over.

akaheather wrote:Have we come to any consensus as to November or September? I'd like to place my bet on October, just to be contrary.

All I read in that Opexa link was that it would be in the forth quarter of this year and October is within that time frame. Oh, I forgot you wanted to be contrary!
Bob

Quote from Bob

If anyone runs across an official statement from Opexa talking about a planned release date for interim data, please share.

Interim data will be published about one month after 6 months after the 75th patient has received his/her first treatment. My dart still hits the wall near the end of the 4th quarter.

IHaveMS-com wrote: Interim data will be published about one month after 6 months after the 75th patient has received his/her first treatment. My dart still hits the wall near the end of the 4th quarter.

Hi Tim,
First, you're supposed to be on a relaxing fishing vacation and not worrying about Tovaxin.

Second, now I've got a visual of an internet addicted red haired guy trudging miles and miles of dirt roads with his laptop to the closest internet cafe. Evidently the fish aren't biting.

Third, believe it or not, exactly what you mentioned was what I had in mind but it seemed contrary to post that in the same post in which I questioned whether or not the FDA would allow it so I deleted that part. Must be you had mentioned those stipulations because I can't imagine I came up with that on my own.

I'll forward my shipping address. With a little dry ice my share of the cleaned fish should make the trip to Laingsburg just fine!

Thanks for the info!

Bob

Hi All,
I can't seem to locate the thread regarding length of time from procurement to injection so I thought I would add my 2 cents here. I got the call today. I was told that there was another mandatory 21 days from this point. That makes my 1st injection July 6th (first available date due to 4th of July holiday). My procurement was April 12th. Basically 11 weeks total.
Lars

Lars wrote:I can't seem to locate the thread regarding length of time from procurement to injection so I thought I would add my 2 cents here. I got the call today. I was told that there was another mandatory 21 days from this point. That makes my 1st injection July 6th (first available date due to 4th of July holiday). My procurement was April 12th. Basically 11 weeks total.
Lars

Hi Lars,
Going from my poor memory, I've heard everything from about 10 weeks at the earliest and it sounds like it's been running about 14 weeks so far, so 11 weeks is good. Must be you've been doing some flirting with the coordinator!
Bob

Bob,
Absolutely!!
Lars

IHaveMS-com wrote:Quote from Bob

If anyone runs across an official statement from Opexa talking about a planned release date for interim data, please share.

Interim data will be published about one month after 6 months after the 75th patient has received his/her first treatment. My dart still hits the wall near the end of the 4th quarter.

And when they publish this information, dear friends, I expect Opexa stock to go through the roof and a truckload of reps from the Big Boy pharmas to come knocking on some doors in order to get a piece of the action for Phase III.

But let the reader beware: I voted for Morris Udall in the '76 Democratic Primary, too, with similar luck my entire career...

Jane,

I was thinking the same thing. However, their stock is low now and I would imagine Opexa will be known as a subsidiary of Biogen or Teva before it goes up!

Loobie wrote:Jane,

I was thinking the same thing. However, their stock is low now and I would imagine Opexa will be known as a subsidiary of Biogen or Teva before it goes up!

Until recently, the thought of this really annoyed me--after all, the Opexa people have done the dog-work making this wonderful stuff so possible.

But I have to keep the big picture well in mind: they're going to need those big bucks when it comes time to segue into Phase III. One of my husband's stock reports claimed they've got an outlay of a million bucks a month for this--and that's just the follow-up for the first round of guinea pigs and those of us in Phase II.

So I'm going to have to endure having my sense of fair play outraged and just deal with it. After all, it'll mean treatment for so very many people.

Let's just hope it never turns into the mess Tysabri did--all that price-gouging when it was re-introduced. To think of patients not getting a workable therapy because of cost considerations--that's obscene.

So if someone can allay my fears about Tovaxin turning into a cash cow for a Big Shot pharma and not getting where it needs to go, I'll be okay.

That and making sure the doc who got this ball rolling in the first place gets the Nobel Prize for Medicine. At the very least!

And by the way,

Welcome to another buckeye! Homer's pitching as we speak!