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Bullboard - Stock Discussion Forum Spectral Medical Inc EDTXF


Primary Symbol: T.EDT

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... see more

TSX:EDT - Post Discussion

Spectral Medical Inc > This is more or less what was said...
View:
Post by gebremeskel on Mar 06, 2024 5:53pm

This is more or less what was said...

Dr. John Kellum

With regard to confidence in the preliminary data, although we have not and we will not conduct any formal analysis of ... data until we complete the trial, we continue to be very pleased with the results so far. Our confidence in the results of the trial remains high. 

In November, we published the simulation of the of the likely Tigris results using Bayesian statistical analysis. The paper was published in Critical Care...and was co-authored by our site investigators. The first author of the paper was George Tomlinson, a highly respected biostatistician and expert in Bayesian statistics in the University of Toronto. The results of these simulations furthers our confidence in the final outcome. 

You may have noticed, however, that the language that was used, have used in the past, "exceeding expectations” has been removed from recent press releases. 

On advice of consultants and in deference to future FDA deliberations, we are taking a more conservative and less quantitative approach to describing our results. In particular, we're steering clear of any language that might suggest that we're conducting interim analysis which would result in statistical penalties. 

What we can say, however, is that we're quite pleased with the results and we're confident in the outcome. 

 
Comment by daviking on Mar 06, 2024 6:33pm
gebremeskel When did Kellum, say this?
Comment by gebremeskel on Mar 06, 2024 6:43pm
In the investor call. The audio has been posted on Spectral's website
Comment by hmmmmmmmm on Mar 06, 2024 6:38pm
Yes, Dr Kellum has been very clear and consistent that they "will not conduct any formal analysis" and that "conducting interim analysis would result in statistical penalties". He has also been consistant and clear that "crude data" is not statistical analysis- as printed/ stated twice in the AGM. This was the case until we reached 90 and at the behest of Baxter the ...more  
Comment by mercedesman on Mar 06, 2024 6:44pm
Another timely and relevant post g ! Apparently there are a few Stuart Smalley's on here that need their daily affirmation.   "It's good enough, it's exceding expectations enough, and doggone it, people like it" Later I'll post a reminder of the only PMX affirmation I needed - and it occurred sometime in 2023.  MM 
Comment by BlueJays9293 on Mar 06, 2024 7:22pm
Private equity getting involved a mere months before the Vantive spinco date, was/is the most under-appreciated piece of news that Spectral shareholders have received.  They had all of 2023 to kick it around and yet they chose now to get involved.         
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