An end run...

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Posts: 35
Joined: Thu Aug 30, 2018 9:05 pm

An end run...

Post by Gwikley » Fri May 17, 2019 4:50 am

The extended time frames are disappointing. But the idea of a sit down with the FDA and trying an end run around needing a dual trial for MF given the current stats, is a novel idea worth pursuing. Kudos for the crew that came up with it

Posts: 210
Joined: Fri Jul 20, 2018 5:13 pm

Re: An end run...

Post by biopearl123 » Fri May 17, 2019 5:06 am

Currently traveling. Will post later re conf call and abstracts. Am struck by the inclusion of a significant p value and a real attempt to establish statistical validly in MF study. Many including myself have suggested Scarlett will avoid a PIII in MF. Using matched controls even though historic, is an effort to do so. bp

Posts: 100
Joined: Sun Apr 03, 2016 11:27 pm

Re: An end run...

Post by cheng_ho » Thu May 30, 2019 2:35 pm

I agree, this is somewhat encouraging. They probably don't have useful historical controls right now because of the differences between different hospitals' protocols and generally bad databases (HIPAA didn't help the already-backwards hospital medical databases).

But that doesn't that the necessary data doesn't exist, if they hunt it down.

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