Sell... now if......you believe, as the market seems to believe (based on the current SP) , that there is almost ZERO (lets call it 2%) probablity of approval of PMX by the FDA.
This despite:
- Phase 3B Trial being labelled "confirmatory" meaning they just have to reach the "meh" goals of Euphrates, but now armed with much better data and selection criteria.
- indications from Mgt that the Tigris Trial, so far, is "exceeding expectations".
- Favourable Trial paramaters granted by the FDA (Open label, Bayesian, 2:1)
- likely far greater need now (Covid leads to Sepsis - see gut dysbiosis and endotoxemia in advanced/severe Covid patients)
- 300,000 safe uses world-wide
- Meta analysis data with 10's of thousands of participants supporting a PMX mortality benefit.
- Euphas 2 (early Trial stoppage for efficacy reasons)
- Euphas Registry ( closing in on another decade of gathered evidence and proof)
- PMX being supported by Ronco as a Golden Hour sequential therapy. (Ronco is likley the world's leading authority on Sepsis, and AKI)
- Kellum joins Spectral in 2021 (jettisoning all other ties with other co's including HP co's) Loads up on options and shares all above .425
- mounting RWE evidence in support of PMX, and not just for Sepsis
- it is backed by a multi billion dollar Japanese congolmerate
- it has a distribution agreement with a multi-billion dollar Company that owns the ICU supply market.
And also sell, if despite all of the above, you believe that all of the following assets/pieces are totally worthless to other market players as well:
- Dialco = virtually worthless. Even though it is likely (it's a question of when not if - per Seto) to be the 3rd or 4th entrant in the about to greatly expand, HD market, with Diaco's entrant, offering "ground breaking" new technology
- never mind that the first two entrants into the HD market, have captured a market cap of $ 2B USD for their Home Dialysis machine only
- never mind that DIMI will smash most if not all barriers to adoption that the competition does not.
- the FDA approved EAA is worthless despite its utility (at the very least) as a ICU triage tool to rule out Sepsis. And with worldwide exclusive rights to boot.
- $ 80 million in past Trial costs, and acquired IP has no utility to other biotechs (e.g. even just as a a tax loss shelter)
- That they have valueless world wide & patented rights to the only HP pump on the market (SAMI) = utility for the Golden Hour sequntial therapy approach advocated by Ronco
MM