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Russia and Eastern Europe are notorious places to run RCTs. There was a video a while ago by an investigator who talked about an acquaintance who went missing in Russia after trying to stop his trial from being compromised.
Supposed to be a reply to TGW’s post - which definitely had TMI. Must have hit the wrong button. Meh.
**T**M**I** !!!
"Substantial fraction"? How do you know that? Herpes found 4-5 docs who claimed the placebo harmed patients or questioned whether the results were valid - I seriously doubt they are in the majority.
He talked to 6 cardiologists, and 5 expressed reservations:
Glad u sold ur options! Ur much more fun wo them!
PS Am now long. Do u need to sell now?
FGEN - Anyone interested in FGEN (long, short or just scientifically) should watch the below video.
It is easily the best backgrounder I've seen in biotech land for a variety of reasons:
a) it doesn't elide the difficulty of determining causation without an RCT
b) it gives huge depth of the history (regulatory and scientific)
c) it gives both the positive and the (potentially) negative possible outcomes.
https://nephrology.hosted.panopto.com/Panopto/Pages/Embed.aspx?id=1ac66070-aa6c-475b-84e3-fdcc79dc5a76
#ASCO18 HER2 space relevent to Daichi, $ZYME and $MRSN
— Clark H (@Clarksterh) June 2, 2018
Tweet compendium (so far): https://t.co/m0hfmCCrVD https://t.co/tm0FfcqXTp https://t.co/IOoLheMkBS https://t.co/4tb6Ryp6WG https://t.co/4u7XZDv6SV https://t.co/Rvxhqf6f0R https://t.co/slSOun6AtI https://t.co/pCeQxQy7Sj
TOCA
SLS - a lot of strange things in that PR, among them:
1) DSMB gives out results for a blinded trial, albeit single blinded, at interim despite not being stat sig overall
2) my guess is the non- picked subgroups (ie hormone treated and not TNBC) probably had an HR meaningfully above 1. If so this implies the HR seen in the subgroups is suspect.
3) The company announced complete enrollment of 300 people in Sept, but the PR was only for 275. Where did the other 25 go?
4) why does the relative risk reduction not equal 1-HR?
5) and just a reminder that this is a GALE drug and a GALE trial.
SGEN