1st Qtr Report, page-7

First 7 Last

Share
Profile

Follow
xc_mse

2,169 Posts.

15

06/05/15

11:39

Post #: 15226279
Share

Originally posted by xc_mse ↑

On the negative side it looks like another month or two before the bulk of the centres are back on line, the protocol changes having to be run through their ethics? Committees.
Positive side we have 50 odd doctors roughly two each from all the activated centres as well as six centres yet to be activated, one would assume very busy people giving up substantive work time to attend trial meeting. Real enthusiasm.
Back of the envelope estimation.
We know the trial has no significant safety issues.
We know from the feasability trial that the first 30 days was clear of HF events. Surrogate for treatment arm in current trial.
We know that of the 50 patients waiting for implant only 26 made it to through the first 30 days. Generously allowing for 4 "recoveries" plus 10 "unrelated HF deaths" (same as at 6mths for treatment arm of current trial, undoubtably a serious overestimation) leaves us in this surrogate population for the control arm of the current trial, a conservative 20% serious HF related events at 30 days , including many deaths and death equivalents ( ie. Transplant and LVADs ) v zero% serious HF events in surrogate tratment arm.
How long can this trial continue if your treatment arm is improving and your loosing 20% of your control arm every 30 days to HF events?

Expand

Listening to the web cast again, Corrections.
19 of the 23 activated centres are sending representatives.
should use "patients identified as suitable for trial" instead of "patients" waiting for implant".
Drop off in patients was over 60 days not 30.
Still contend the that this patient group is a good surrogate for control arm and its a train wreck.

SHC Price at posting: 2.5¢ Sentiment: Buy Disclosure: Held
1 Upvote

0 Great analysis

Reply

Top Stories

IMR

Imricor raises $35M to pursue growth and expansion into Australia and NZ

FG1

Flynn Gold flags mid-grade drill hits and always eye-catching rock chips

Talking Australia's very competitive property landscape: Realty Talks

LKE

Lake Resources implies news article on job cuts made up; non-core sales "not material" and no rule 15.7 breach

Warren Tredrea’s weekly sports business wrap: the latest on business in sport

Wealth Within considers potential takeover targets in Australia's booming infrastructure industry

GNX

NSW approves J-POWER's $380M buyout of Genex Power, giving it ownership of QLD net zero project

AI stocks: What to expect in 2024-25

Week 29 Wrap: Trump in spotlight again; China's Third Plenum a yawnfest; RBA's August move a mystery

MCT

Metalicity looking for offers on Admiral Bay zinc project