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Spectral Medical Inc T.EDT

Alternate Symbol(s):  EDTXF

Spectral develops devices for unmet medical needs. Sepsis occurs in 1.7M Americans/year causing 250K deaths, often caused by endotoxin. Our devices measure and remove endotoxin from the bloodstream. An FDA confirmatory trial is underway. Dialco, a Spectral sub, offers SAMI, a novel instrument for renal replacement, cleared by FDA. Dialco is seeking FDA approval for DIMI a unique home dialysis enabler. These devices have large commercial potential


TSX:EDT - Post by User

Bullboard Posts
Post by RetailRubeon Sep 08, 2010 3:48pm
243 Views
Post# 17426001

Is trial late? Maybe not ...

Is trial late? Maybe not ...I always thought SDI said they were going to have everyone enrolled and the clock running by June 30, 2010.  So I was disappointed when their 2Q financial report did not announce that.  I thought "they're late".)

So I re-read what they actually published.  I have concluded that I saw what I wanted to see, not what they actually said.

Their MD&A for year-ended Dec/2009 (published March 10, 2010) says on page 4:  "raised 19,500 of additional capital, which funds will allow it to start a trial in the first half of 2010."

On Feb 28 2010, AKeh posted his/her notes from the Shareholder Special Meeting.  Post is titled "Fiddy Cent".  Trial is nearing approval.  15 sites.  Recruiting 1 patient per month per site.  Total enrollment of 360 patients.  Each site will start only after local ethics/institutional approval, so simply multiplying the numbers doesn't reflect the actual time line.  Takes 2 years to complete.  This tells me there is no way they could have achieved full enrollment by June 30.

Clearly, "start" meant start evaluating and qualifying sites.  But SDI was vague, probably because it meant a more powerful sales message during the investment banking phase.  Dupes like me hear what we want to hear.

The MD&A for 2Q/2010 says "length of the trial is 24 to 30 months after all sites are operational, with an interim analysis planned at the mid-point of the trial."

I now interpret this as three key milestones for them to report to us on:

1)  End of 2010:  everyone enrolled
2)  End of 2011:  mid-point evaluation  (add a few months to analyse and issue news release)
3)  End of 2012:  final results (add a few months to analyse and issue news release)

As they say "Nothing to see here.  Move along."  If you are a trader, you would likely sell and come back in Nov/2011.  For the rest of us investors, time to put this stock on cruise control, but buy occasionally from the traders compelled to sell at the bargain price of 32 cents because of the thin market.
Bullboard Posts