The forgotten (underestimated?) catalyst? E2If I am not mistaken they mentioned that the Euphas 2 results are in Peer-review and should be released very soon. This data (regarding PMX use guided by the EAA) has been collected in Italy for more than a decade.
Reminder:
In 2010, an international group of investigators launched the project EUPHAS 2, a multi-center, collaborative study, aiming to create a large database concerning Toraymyxin® treatment. The scope is to evaluate the effectiveness and biological significance of endotoxin removal in the clinical practice.
https://www.euphas2.eu/
Per Spectral NR Jan 2023
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.
https://stockhouse.com/news/press-releases/2023/01/12/spectral-medical-provides-update-on-tigris-clinical-trial-and-other-business
If, as expected, the more detailed analysis of Euphas 2 (peer-reviewed results) reveals even more conclusions, and speaks to a similar "exceeding expectations" mortality benefit, then does that not impact the probability of FDA approval? Does that not then imply it's more likely to be just a matter of time (completing the trial to one stage or another), vs. just about passing a statistical threshold within one Trial without reference to on-going and evidence enhancing EAA guided real-world studies? If so, would that then bring EBITDA calc's more into play, with less of a discount (a more miniscule discount?) for uncertainty ?
Just asking.
MM