Spectral's "Reuters update" 9:30am October 3 2016
Last Friday's "update" looks far more like a side order of delay to accompany the consistent negative messages being sent from our analysts and 70 cent financing partners.
Walker has said nothing to shareholders by way of a company news release but suggested more columns and a 2018 target to the gal that appears to be a "close follower" of the company as her July 13th "
small canadian drugmaker" article remains the
website welcome mat for any curious observer.
Firday's "update" pushed back the SAM pump approval
again ( now near 1 year behind initial for a blood pump ), this was "played with" as a working unit nearly 2 years ago at the AKI conference in San Diego.
We were told the "pre-sub" meeting with the FDA was set for early November, now it's February, allowing full tax loss selling, January option granting and the ability of a 3 CENT target and an UNDER REVIEW to "work it's magic"
These guys OWN IT ALL and appear to want more...here is what Reuters posted 1 hour after the Oct.3rd release and since then the company has told retail holders
NOTHING and with tidy delays. arguably LESS
The trial did not meet the main goal of absolute reduction in mortality rate at 28 days but did demonstrate beneficial treatment effects, Spectral said on Monday.
"We proved beyond doubt that endotoxin is bad and taking it out is good," and Spectral will discuss with the U.S. Food and Drug Administration the next steps, Chief Executive Paul Walker told Reuters.
A smaller-than-expected decrease in endotoxin adversely affected the rate of mortality reduction, he said.
If we can show "more columns take out more endotoxin, then I think we can get approved."
There are no specific FDA-approved medicines for the treatment of sepsis, and there have been several high-profile clinical failures.
The leading cause of hospitalizations in the United States, it can result from a simple cut, routine surgery or infections associated with chronic disease.
Infants, the elderly and those with weakened immune systems are most at risk.
In extreme cases, a dramatic drop in blood pressure can lead to life-threatening septic shock, the category of patients Spectral is targeting.
Toray has been selling the product, the Toraymyxin system, in its home market since 1994 and through distributors in Europe since 2002. The system is also approved for use in Canada.
Still, data supporting use of the device is intensely debated, with trials conducted outside of Japan and Italy failing to prove its efficacy.
Walker expects Spectral will now need to conduct an observational study to show that four columns, for example, will take out enough endotoxin to make a significant difference in mortality rate.
If all goes well, this could mean the device could win U.S. approval by early 2018, he said