Relief Therapeutics Holding AG (RLFTF)

[Inelgr]

Don't put too much stock (no pun intended) into the 28 day mortality marker.

This trial started May 15, 2020

Think about that for a moment.

Has our understanding of COVID-19 changed since May of last year? Yes, it has.

Has the Standard Of Care changed since then? Yes, drastically.

The median time to death has gone up since it first emerged. Example, last June, it was ~ 13 days and last Dec it was ~ 19 days That means, identifying and treating cases has improved. In other words, people are not dying as quickly now...as they were when this novel virus emerged.

If they were to design the study today, such a primary goal of comparing mortality rates at 28 days probably would not be included because the understanding and the treatment of the disease has changed, significantly, in the last ~ 8-9 months.

A few big ticket issues that remain are lengths of hospital stays (expensive) and lengths of ICU stays (very expensive). In both cases, the addition of Zyesami to the SOC nearly halved those stays.

That's significant, for many reasons, even beyond cost.

Also, very significant, as Dr. Javitt explained in today's interview with Dr. Yo (beginning around 6:10)...as before...the major mortality difference seen to date occurs at/beyond the 60 day mark. They didn't see a mortality difference at 28 days from earlier last year, and they still didn't. So, nothing has changed in that regard. There has been NO new negative outcome.

Overall, 81% of RLF-100-treated patients survived beyond 60 days, compared to 17% of control patients. Patients treated with RLF-100 demonstrated a 9-fold increased probability of survival and recovery from respiratory failure, with a high degree of statistical significance.

https://www.biospace.com/article/releases/neurorx-and-relief-announce-topline-efficacy-data-from-patients-treated-with-rlf-100-aviptadil-under-the-u-s-fda-expanded-access-protocol-authorization-for-respiratory-failure-related-to-critical-covid-19/

Now...the new 60 day mortality data may not be as significantly different as 81% vs 17%...because our understanding of COVID-19, and all treatment options, have continued to improve. Perhaps this time, it will be more like 80% vs 30%. We'll see.

In the interview, he also stated: Remdesivir - Mortality isn't the story. The story is getting people home to their families sooner.

On that score, the addition of Zyesami produced clearly significant positive results.

In no way, was the preliminary data that was released the other day a negative surprise. In terms of the arbitrary 28 day marker...it's exactly in line with what they have been showing for many months now in the Dr. Youssef Houston study.

Let's see what they report on the new, more longer term, 60 day data.

Inelgr..I agree. There seems to be a disconnect between what JJ said this morning and what we see in the official PR. However, the PR did officially state the following not-so-good news. We cannot ignore the following fact......

With the improvement in survival since the start of the pandemic, differences in patient survival were not seen at day 28, and patients are now being followed through day 60. The study has not identified an overall difference in the stated primary endpoint of recovery from respiratory failure from summary data.