Is expected by Sept.30th. We are waiting for the requirements in order to provide an interim analysis on our pivotal phase III trial for severe sepsis ( septic shock ). During his recent presentation in NY, our CEO, Dr.Paul Walker explained that he expects the interim analysis to be available by the end of Q1 2013. The FDA is allowing Spectral to "look earlier" at the results, why you ask ? Because more people are dying in this trial than expected. Is this a problem ? Apparently not, if you reached a grade 9 level of math and look at the numbers provided it's not too difficult to determine what's going on. Through the use of Spectral's EAA diagnostic, they are choosing the "sickest of the sick", and therefore those in the "standard of care group" (placebo) appear to be dying at a significant %, this would push the overall mortality rate higher than expected ( 35% vs. predicted 27.5%) The BILLION+ question is what percentage is each group responsible for ???? Initially the requirement was for 180 patients at "interim ananlysis", this number has now been pushed back to a second interim ananlysis scheduled for Q1 2014. At August 15th 2012 we had 62 patients officially enrolled in the trial, I would expect that the FDA will allow 100 as the number for the first interim analysis in Q1 2013. We are VERY close to significant activity or SIGNIFICANT FAILURE, given the activity, share price, and massive dilution to friendly hands at friendlier prices, I would be SHOCKED ( "septicly if you will" ) with a negative result.
Walker did a fantastic job of presenting the data to the handful of brokers in NY on the 10th. He was extrememly confident and the data he presented was very encouraging. Because our primary endpoint is 28 day mortality, deaths in the trial must be reported ( SAE's) This means that data flow from this trial is well above and beyond 99% of trials run. The fact that Birch Hill continues to pour money into this story, given their knowledge, and the supporting data is highly positive.
Bear in mind, it's still important for us to remain range bound while the .08 deal at Meddwell gets finalized. Yesterday activity at MWC was a telling tale of just how important it is to keep both companies right where they are.