Opexa (OPXA) Surges on FDA Fast-Track Designation.

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Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby TWG » Tue Nov 08, 2011 6:57 am

Diagnosed with MS in Feb. 14 2000! Was a Tovaxin guinea pig.
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby TWG » Wed Nov 09, 2011 7:33 am

More on fast track status. It seems it is for SPMS, RRMS at a later date.

http://regulatoryaffairs.pharmaceutical ... xin-091111
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Postby Lyon » Wed Nov 09, 2011 12:47 pm

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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby sushifishman » Wed Nov 09, 2011 4:50 pm

Here is why.

It is now much easier to get to tovaxin approved by going spms route. Easier from FDA perspective and a phase iib is much cheaper. If approved, tovaxin will most certainly be used as "off label" for rrms.

It should be more attractive for a partnership now that it is fast tracked and will be a small investment for big pharma.
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Vikingquest » Wed Nov 09, 2011 5:03 pm

TWG,

Can I ask, what was your experience with Tovaxin like?
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Postby Lyon » Wed Nov 09, 2011 6:12 pm

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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby TWG » Thu Nov 10, 2011 6:47 am

Vikingquest;
It slowed, or should I say, stopped relapses and I felt it was the one thing that stopped any progression. My walk test etc. showed that if anything, I improved slightly. I have RRMS. during the blinded initial study I found out I was on the real stuff.
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Postby Lyon » Thu Nov 10, 2011 1:21 pm

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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Lars » Thu Nov 10, 2011 4:08 pm

Hi All,
Been a while but last time I checked NOTHING was happening with Tovaxin but low and behold I read the "Motivator" and saw this:
During the coming year, we anticipate that other new oral medications will be submitted for evaluation and potential approval by the FDA, including teriflunomide, laquinimod, and dimethyl fumarate (BG-12). One new injectible, Lemtrada® (alemtuzumab, formerly known as Campath and given via intravenous injection), may also enter or complete the approval process. Several more injectible drugs are also on the horizon, such as ocrelizumab, daclizumab, and Tovaxin®.

What the hell did I miss? I guess I have been to involved with anti-Lingo to notice but I'm a little dumbfounded.
Be Well,
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Postby Lyon » Thu Nov 10, 2011 4:41 pm

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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby CureOrBust » Thu Nov 10, 2011 11:54 pm

TWG wrote:during the blinded initial study I found out I was on the real stuff.
Can we ask how?
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Lars » Fri Nov 11, 2011 8:42 am

Bob,
I'm not sure where the Motivator came up with their positive spin on Tovaxin. Why in the world would that pop up if no further studies have been done, and how can it suddenly be on a track for SPMS? Maybe they are trialing in Mongolia. Sounds like a scam story to make money on their stock.
The Anti-Lingo trial has gone well. One word, Biogen! Very tight ship, very hopeful, and opposed to Opexa, no worry of the plug being pulled. No adverse effects on anyone to my knowledge and though the staff would like us to be quiet, there has been some seemingly wonderful responses to the drug. I have seen no personal improvement. I think they are gearing up for Phase 2 in 64 locations I believe. Remember Bob, this is not an M.S. therapy per say. It's design is to re-mylenate and repair Axonal (that cannot possibly be spelled right!) damage. I have 3 more visits over 3 months. No more drug just MRI, blood, etc.
Hopeful to join phase 2!
Be Well,
Lars AKA Still Pissed at Opexa
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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby sushifishman » Fri Nov 11, 2011 9:08 am

Opexa is not scamming ANYONE

Do your due diligence and you would know that they have been examining their data. See presentation from September:

http://www.opexatherapeutics.com/files/ ... 202011.pdf

Explains what they have been doing very clearly. Getting Fast Tracked is not a ploy to make money. Explain how one would make money? Read the details about their options and you would know.

Tovaxin is still a viable treatment and getting SPMS approved is a gateway for using it "off label" for RRMS.
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Postby Lyon » Fri Nov 11, 2011 10:00 am

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Re: Opexa (OPXA) Surges on FDA Fast-Track Designation.

Postby Vikingquest » Fri Nov 11, 2011 3:45 pm

Lyon, just to be clear, your wife was in a Tovaxin trial and she hasn't had any relapses or progressed since then? When was her last Tovaxin injection? And if you don't mind my asking, what were her relapses like before?

Thanks

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