4 deaths in implant arm doesn't seem remarkable.
C-Pulse has been continuously pushed out of its target HF demographic into a more desperate group willing to take the risk expect this to be confirmed in conference call.
Even if stable and out of hospital Class 4 HF patients have a 20% chance of dying within a year.
Indicates even if HF is stabilised via C-Pulse a substantial number of patients are going to die.
All C-Pulse patients have been hospitalised in the previous twelve months.
This greatly increases the risk.
We won't get access to the control arm statistics, but given the FDA moved interim analysis forward deaths as expected in the control arm would motivate. Odds are the control arm has had more than 4 deaths.
The US is coming out of winter, would this have hit HF suffers, greater risk of falls, lower scio economic groups in trials? less than adequate heating? Social commentary an interesting aside?
I would like to know if we are still getting the PIL problems?
How far are we into the Fully Implantable? A lot of effort is obviously going into making it attractive to class3. Is it being held back till completion of trial?
Deaths are a scare but my main interest is the fully implantable, hope someone asks some solid questions on this.
SHC Price at posting:
2.5¢ Sentiment: Hold Disclosure: Held
