InvestorsHub Logo
icon url

PlentyParanoid

06/21/18 1:50 PM

#231674 RE: frrol #231670

Maybe confusion is a product of several companies not bothering with press releases about data lock. Big pharma sometimes ignores even to announce last enrollee or last required observation/event. Then they sit on data until a suitable conference comes along (like Novartis did last year). Several drugs on market make stuff from a single trial very non-material.

This, of course, won't apply to small struggling biotechs like our IPIX. I expect Leo to rush topline data out while documenting every step on the way with press releases.
icon url

loanranger

06/21/18 1:54 PM

#231675 RE: frrol #231670

I don't quite understand this:
"Not sure why anyone would be surprised or ask about this, IPIX even did data lock announcements on its recent trials"

From your earlier post:
"Keep in mind the process, and note that IPIX involvement is at the very end. It is in the dark until then, aside from anecdotal word or a planned interim peek.
1. CRO finishes the trial
2. CRO completes the raw data
3. CRO cleans the raw data, making it analyzable
4. CRO locks the analyzable data
5. CRO merges the treatment code file with the analyzable data (ie, matches up who got placebo and who got drug). This step is the "unblinding."
6. CRO gives the unblinded data to IPIX
7. IPIX analyzes the data
8. IPIX releases top line results
9. IPIX releases follow-up results as its analysis continues"

Your email from the CEO seems to indicate that they are at step 4.
"The anticipated sequence of news will be a) Data Lock, and b) thereafter, top-line results"
"The trial will be unblinded shortly."

It seems silly to parse that any further. Or is it? We've been provided the sequence, but if the secondary outcome and questionnaire issues are as tricky as we've been told then "thereafter" may not be that soon after "shortly".
icon url

slcimmuno

06/21/18 2:31 PM

#231678 RE: frrol #231670

The Clinical Trial Life Cycle and When to Share Data

https://www.ncbi.nlm.nih.gov/books/NBK286004/

Posted this chapter link a while back - the deepest of deep dives... worth a read... lots of times data releases take lotso time, priority given to publication, with recommendation at least w/in 12 months (!)

I tend to think once PRU Dbase lock occurs, we should find out at least toppest of Topline — whether great/good/mediocre/fail — within probably a few weeks

Just my opinion