Spectral Medical Inc T.EDT

Top Line Tigris Results by April 30, 2025 ?

[gebremeskel]

In the last press release Spectral estimated that enrolment should be completed by the end of 2024. Top line results should be released 120 days later, which brings us to April 30, 2025.

If all goes well, FDA approval and the start of commercialization should happen by the end of March 2026.

The Euphrates trial demonstrated that patients with EAA results between >=0.60 and <0.90 experienced an 11% 90 day mortality rate benefit. When the Tigris trial was two thirds complete we heard that crude mortality results exceed efficacy targets.

If Tigris results confirm Euphrates results, PMX treatment of the targeted population will mean that 11 more patients out of every 100 will live.

[mercedesman]

Hey G.  A good but ( IMHO) conservative timeline and expected final benefit.  If I had to guess, I'd say Top Line by Feb/March 2025  FDA final approval I expect before the end of 2025 -  see Breakthrough Device designation.  Spectral went out of its way to highlight that Tigris was exceeeding expectations, even adding a few extra adjectives at times

[gebremeskel]

Even better! I'm rooting for that early takeout!

[BlueJays9293]

I'm starting to think that CG's closing of Vantive and their closing of Spectral, will happen in sync to each other, maybe not on the exact same day but close to it.  I just feel like each one is so important to the other.  From the PMX cartridge being so vital in driving the Prismax razor blade model, which drives Prismax into further domination of their ICU CRRT market share

[mercedesman]

Correct  The whole ( PMX, EAA, oXiris, prismax , NA rights, world rights, etc. ) is worth way more than the sum of the parts.  I agree that quick succession deal is most likely though that will depend upon how negotiations are progressing on a complex assembly of the parts.  Spectral will be but a small footnote in the history of medical science  MM 

[BlueJays9293]

So I glanced thru the Carlyle/Baxter purchase agreement for Vantive, to try and get some color on when their deal might close.  Looks like February 12th is when the Termination Fee of $180mm USD comes into play.  Knowing this I figure December is the month Carlyle Group would prefer for the Vantive deal to close.  They could maybe push it to very early January, but that gets risky