Well since several of us here are in both ICU ( thx Ernie ) and UNCY ...I'll address both here .
Let's all agree that all opinions submitted respectfully, are welcome .
Yes I know I've been snarky at times but I'll do my best to refrain from such .
Re ICU and a Fresenius buyout out .
That would be way down the line . Fresenius would want FDA approval and a Class 3 device classification which would extend their patent life 5 yrs past the current 2032. . Currently Fresenius has right of first refusal for making the device ...if ICU's SCD filter is approved for the adult population. .
Having both a Pediatric approval and an Adult approval increases the chances of a Class 3 device designation.
Now about ICU's adult trial .
The FDA apparently funded , or helped fund the Pediatric trial ...very unusual . And only required 16 patients be enrolled for what was a pivotal trial .
That is almost unheard of .
Then the trial showed spectacular results ...25% absolute reduction / 50% relative reduction ...in mortality
So the 8 in the control ...4 unfortunately died ...50% mortality
The 8 with SCD filter added ...only 2 unfortunately died ...25 % mortality.
In addition all those on the filter that survived went on to regain full kidney function ...again amazing results .
The results in the adult population are unlikely to be as good due to older age , many will be diabetics with underlying long term heart disease etc ...so separation between control and control plus SCD filter unlikely to be as good as the pediatric trial .
So the problem for the adult trial ... they are locked into the same trial inclusion requirements as the pediatric trial BUT need to enroll far more patients as per FDA requirements for larger potential patient population .
So rather than a trial only with dialysis patients admitted to the ICU with Sepsis .....that can be up to 100,000 patients each year in the US ....they can only recruit such patients if they also have another organ failure ..such as lung or heart function crashing .
So they're trying to enroll the sickest of the sick ..in a very narrow window when a second organ is failing ( kidneys have already failed ) ....but before the patient actually dies .
Its taken them over 1 yr to enroll the first 100 and they need a total of 200 enrolled .
So now its a IMHO a mad rush to get the rest enrolled before then end of year and they start running out of $ again.
Thus the frantic capital raises recently .
They currently have an interim review underway ..results I expect late Sept . Theres a slim chance FDA could stop for efficacy or the Co may ask if they can reduce enrollment to say 160 .
If the enrollment is only 10 per month ...they would need to the EOY just to get to around 160. .
Based on the success of the Pediatric trial, FDA will want this trial completed and may take a more lenient approach ...we'll see.
So IMHO ICU is far risky than UNCY .
With UNCY its really about timing as IMHO OLC will be approved ...its just when .
When approved , in TDAPA and 100% reimbursed thru Medicare ...it's just a question of whether all the clinics stock OLC. ( some smaller clinic aren't stocking all the pho binders for various reasons ) and if the MD's offer OLC to their patients who aren't at pho lowering goals ...which is most of them.
Re timing ..its really how the market reacts to
1) a Class 2 re submission
2) a funding round .
At a certain pt market will look past the bad news ( if there is any ) and time the FDA approval.
I'll be looking for when the stock does not close down on bad news ..
What I like to see opening lower and closing higher on bad news ...the reverse of what we saw for the REDUCE- IT trial ...for you AMRN fans reading this ...where we saw the stock pop on the R-IT approval news then close lower on very heavy volume .
For me an obvious sell signal .
JMO
Kiwi
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