mercedesman wrote:
Spectral was formed to:
1. Secure FDA approval for Toraymxin in the US, in exchange for assignable Rights to the NA market.
presumably they were selected in part due to Dr. Walker and his history with the development of what will likely become the International standard companion diagnostic (the EAA) - which will determine when/if PMX is needed, duration of treatment, capacity of filter, etc.
2. Secure FDA approval for Infomed's CRRT pumps in the US, in exchange for assignable Rights to the NA market.
presumably they were selected, in part, due to the interdependence of PMX, AKI, the golden hour, hemopurfusion and the need for future CRRT equipment to tackle all forms of blood filtration and especially including for PMX. It would also serve to differentiate SAMI and DIMI from the competition, once PMX achieves FDA approval (and is accepted as the first new treatment for Sepsis in decades)
Period, end of story.
Spectral did not invent Toraymyxin...they will not manufacture it (that's for Toray to do)...they won't even market it (that's for Baxter to do)
They did not invent the SAMI nor the DIMI..they will not manufacture it (Infomed will). I doubt that they ever will sell or market it in a significant way without a logical partner, distributor (as was done with Baxter and PMX).
To recap, Spectral doesn't need to market, sell, invent, roll-out, manufacturer, etc etc. They just need to secure 2 final FDA approvals.
Then it's the END GAME !!!
Will both ponies fail when asked to perform their tricks in front of a real live audience (despite years of training/practice in a dark barn?) Will both succeed? Will Barnum & Baily buy the trained ponies? Will a willing partner/buyer come along just before said approvals (e.g willing to "roll the dice based on Interim data"?, open label results?, or "make a bet" on the probability that DIMI gets over the final and most important hurdle given the rising importance of Home Dialysis)? Let's see.
Insiders grabbing all they can (albeit on the cheap) gives me a clue. Not a sure thing, but undervalued vs the upside for sure (and by a country mile)!
All IMHO
DYODD
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LGBTQ2S+
MM