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

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Comment by gebremeskelon Feb 22, 2024 1:01pm

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Post# 35893665

RE:RE:RE:Data

On the call they talked about Baxter not wanting to take the "risk" of looking at data and the danger of released data being construed as an "interim analysis" that might somehow affect later FDA deliberations. They talked about bad optics and the possibility of a "data penalty"

I wonder if there is a more knowledgable poster on the board who would be willing to explain what this is all about.

hmmmmmmmm wrote: As per pg 14 and 18 of the Anual Meeting Presentation:

"At 90 patients Baxter will have access to raw data (no statistical analysis)… potential opportunity to release crude data to broader audience"

"Spectral Catalysts

• Tigris interim patient enrollment - 90 patients / Baxter milestone payment #2

• Release of crude mortality data at 90 patients"

https://spectraldx.com/wp-content/uploads/2023/06/Spectral-agm-2023-presentation.pdf