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tcm55

02/22/21 7:44 PM

#13799 RE: medchem #13797

My understanding is that the DSMB will stop a Trial for 'futility' or negative results at Phase 2, especially safety.
I rambled and was replying to another Shareholder's accusations and comments...GLTY Sir on your future investments...

Money $hot

02/22/21 8:35 PM

#13802 RE: medchem #13797

55 - Don't take that dudes words seriously. IMO, his clinical trial knowledge is limited at best. A DSMB can pull the plug on a clinical trial related to efficacy. If not, tell him to provide a source beyond hot mess rhetoric. As a matter of fact ask him what type of Board pulled the plug on the Gilead/Galapagos IPF clinical trial?

www.fiercebiotech.com/biotech/gilead-s-5b-galapagos-black-hole-widens-as-pair-toss-out-phase-3-asset-after-flop

Today, the once tightly-knit pair came further apart at the seams when an independent body checked out its phase 3 data for the experimental autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis (IPF).

The outcome was not good. Following a regular review of unblinded data, an independent monitoring board “concluded that ziritaxestat’s benefit-risk profile no longer supported continuing these studies.”



Holla @ me!

Peace,

M$

Dr E

02/22/21 11:29 PM

#13813 RE: medchem #13797

Recommendations frequently *are* made by a Data Monitoring Committee aka DSMB to end a study for lack of efficacy. The prologue, beginning, middle, and end of every clinical study is 'all worded up' with the ethical consideration of the study participants which includes not shuttling them to & from clinics for blood draws, labs, infusions, monitoring, etc for no good reason.

Gilead example

Dr. Wiki's write-up