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Biotech / Medical : Spectral Medical Inc.
EDTXF 0.378+8.7%Jul 22 4:00 PM EDT

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From: Sultan2/5/2024 12:29:20 AM
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Just a little tidbit as a reminder while we were discussing Tigris Trial and the time lines.. No doubt this is a pivotal year for them as soon as they hit the 90 interim patient count..

Last time Eden Study was mentioned by Spectral was on December 14, 2023 news release..

EDEN Study:
  • Completed the EDEN study, a parallel observational study, in which data is collected on patients with septic shock even if ineligible for Tigris. The EDEN study is among the largest ever to examine the full range of septic shock and its relation to organ failure and endotoxin activity. These data will inform subsequent discussions with the FDA on labelling for PMX and provide important data on potential expanded indications for PMX.
Also, let's not forget the following.. This was mentioned a year ago in one of the news releases..
  • EUPHAS-2 is a Spectral-sponsored observational study in Italy using EAA-guided PMX, which is now complete. We have reviewed the topline results, which strongly support the preliminary data received from the Tigris trial. These data strengthen our confidence in our ability to achieve a successful trial outcome as well as potential FDA approval.
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