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dewophile

03/07/22 6:31 PM

#241680 RE: DewDiligence #241673

I just clicked on the link and I don’t think I’ve ever seen anything like it before. I assume there was no cc and the company went ahead and disclosed a (rather unflattering) scripted Q and A related to the top line results. I mean why even hedge like that on the clinical significance of the trial unless you are softening up investors ahead of bad news once you present the full data and or discussions with regulators.

DewDiligence

03/07/22 7:18 PM

#241683 RE: DewDiligence #241673

Typo:

Why would GILD have to consider a balance-impairment if the trial in question was a full-fledged success? (Rhetorical.)

I meant to say balance-sheet impairment.

DewDiligence

06/04/22 6:13 PM

#242712 RE: DewDiligence #241673

GILD details why the purportedly-positive Trodelvy data from Mar 2022 weren’t:

https://www.businesswire.com/news/home/20220603005437/en

The study met its primary endpoint of progression-free survival (PFS) with a statistically significant and clinically meaningful 34% reduction in the risk of disease progression or death (median PFS 5.5 vs. 4 months; HR: 0.66; 95% CI: 0.53-0.83; P<0.0003). The first interim analysis of the key secondary endpoint of overall survival (OS) demonstrated a trend in improvement.

In this context, a “trend in improvement” means non-statsig. OS could conceivably turn statsig in a later data cut, but that’s pretty unlikely.

The viewpoint in #msg-158260565 (from 2020) has not changed.