This Is MS Multiple Sclerosis Community: Knowledge & Support

Copy of the report, p. 31

"We currently intend to use the proceeds from the Feb 2011 public offering for general corporate purposes...and to prepare for and proceed toward the initiation of a pivotal Phase III clinical study... although the(se) proceeds would not be adequate ($7.6 million) to proceed materially beyond initiation... (dosing of the first patient[s?]) or to complete such a study...

"A pivotal Phase III ... is expected to involve 240 patients and take approximately 2.5 years to complete... the costs of such a study as well as ongoing expenses ... are estimated at approximately $35 million.

"Unless we secure at least a substantial portion... we would likely not proceed with the initiation of the study."

Not encouraging, kids.

I'd resigned myself to holding on for getting Tovaxin once it comes to the market IF we Phase II lab-rats didn't qualify for the next study but this make me wonder if Tovaxin will ever get to market at all.

UGH

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Jane the Pain

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I think we're going to be on a roller coaster for about the next six months. And if Opexa has to disband, THEN we'll probably see one of the Big Boys (Merck, Teva, Bayer, what have you) sashay in and pick up this stuff for pennies.

At this point, though, I'm ready for it to happen. If anyone else can get this to market, it's high time to step up and do so. And those millions for development are chicken feed for these Big Boys, you know.

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Jane the Pain

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First time poster.

I first became I Interested in Opexa because my wife has a mild form of MS. I was searching for a company that has treatments for MS.

I have been invested in Opexa since Aug of 2009. It has taken for ever to get to phase iii.

I firmly believe we are on the cusp of phase iii. Take a look at their career webpage. They have added 5 new positions they are seeking to fill. Two added two weeks ago, the others since the summer. Why add over $400k in salary and benefits if you do not think you are going to start a clinical trial.

The big if is can the get $35mm to support this. All indications are that they are moving forward so they must feel that they can get the funding.

Good luck to you all and have faith

I'm figuring that January will kick off their new section with the 240 patients. And then it'll take from January until April before they make a statement about just how much they can and cannot do and how soon their money will run out.


I found that interesting, too. Confirms my suspicions that if Opexa folds, a bigger fish might be hanging around to pick up the pieces. There was a blurb in that report about something/someone in Israel. I'm sure Teva has quite an interest in this so this connection isn't surprising. Just wish things would go a little faster!

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Jane the Pain

I sure wish this would move along fast! TOVAXIN is a super product (my own experience here) and needs to be on the market.

I really think that autologous vaccine should have a separate track for FDA approval.

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Jane the Pain

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Let's hope for some news to tomorrow or guidance at the shareholder meeting

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All I know is they have 6 new positions they are looking to fill. Now at 15. They have hired 4 people since last nov. Why increase your head count by over 50% if things arent moving ahead? Check out the job descriptions on their website. Why do they need these positions?

They will be releasing earnings in the next 9-10 days with some additional updates.


Let's hope for some news soon..