RE:One of the STIG members ( southern tier investment group )..SouthernTierTom wrote: recently asked me about the transition from the phase 2 Euphas trial to the phase 3 Euphrates trial. They asked why Spectral had NO involvement in the phase 2 trial and if the phase 3 trial was simply an exstention of the very successful phase 2 Euphas. My response was that any involvement from Spectral in the phase 2 Euphas would have produced A LOT of both attention to the company and subsequent upward pressure on the share price. He then asked why that was not "sought after"...I had no reply.
Moving on... he asked why the phase 3 was initially a "Natalie declared" failure if it was an exstention of the phase 2 "homerun" ( see 21% absolute benefit and termination due to extreme benefit ) I replied that the phase 3 was really NOT AT ALL like the phase 2. As a matter of fact, it was a potluck of septic patients...really returning to the VERY problem sepsis has had for many decades. Sure, the EAA levels were high, BUT the composition of the patient population was the ultimate "lootbag of patients". As a matter of fact I replied, the most beneficial group of patients ( abdominal ) ended up being the greatest % population in the placebo group vs. the PMX group ( due purely to the random nature of the trial )
WHY wouldn't the FDA have requested a much closer design to the phase 2 Euphas trial for faster access to approval given the stellar safety profile and the clear unmet need...ESPECIALLY in abdominal / translocation patients where anti-biotics are futile and PMX is the globe's top endotoxin remover?
My response;
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Bon appy,
Tom
PS - the STIG may or may not be real / accepting new members and may or may not fully understand the benefit of "mobile goal post$" ; - )
Stellar post !
The 7 people outside of the core group of insiders, that actually understand the importance of what you just outlined, salute you. Here's to a swift return to our Euphas 2 roots using a true "precision medicine" approach this time...guided by (1) a companion diagnostic, (2) a more "tapped in" & influential CMO, and (3) a bit more luck .....vs a gaslighting group of off-putters with a dark, self- serving agenda...while the "accidental" mess was being cleaned up.
MM