Nobody likes delays... ...especially as it delays the endgame and the ultimiate payday to shareholders. And money has time value.
...but could it also make the ultimate payday even bigger ?
I say Yes...
How?
1. More time for the Eden study. Wider label use means greater future revenue possibilities.
In March 2022, the Company launched an ancillary observational study, EDEN, to collect data on patients with sepsis even if ineligible for Tigris. EDEN will capture much needed data on 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 as well as to provide the medical community and the Company a better picture of the addressable population in the U.S.
The Company has onboarded 5 EDEN sites and enrolled 28 patients into the observational study. - last NR
2. More time for more possible proof that PMX should be a targeted therapy for a subset of more severe hospitalized Covid-19 patients (see previous post for but one example of mounting evidence). Ultimately could this mean 20% more to future revenue streams? 75% more?
3. More Tigris patients "exceeding expectations" should improve the overall/final Mortality Benefit (MB). Usually a greater MB = higher price for the device/drug.
4. Other Real World Evidence (RWE). Gives more time for new studies to show the benefits of different dosing (that may not be possible under Tigris). Example, use of more than two cartridges, longer duration treatments, higher capacity filters, treat until the source of the infection has been fixed, treat until EAA levels return to a normal level, etc.
Am I happy about continual Trial delays and enrolment at a snail's pace? Absolutely not ! However, if it results in a higher buy-out price in the end, at least shareholders will have been somewhat rewarded for the wait.
MM