New FDA guidelines

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biopearl123
Posts: 1670
Joined: Fri Jul 20, 2018 5:13 pm

New FDA guidelines

Post by biopearl123 » Wed Jan 02, 2019 2:29 am

https://www.fda.gov/downloads/Drugs/Gui ... 071590.pdf

At issue is whether the FDA will consider the MF study "randomized". Clearly they should since there are two arms. Since good old Janssen closed the study early (I thought that was a great sign then as I thought there was a strong signal and there was--OS but not spleen or CR etc) it is possible that the FDA might consider the study underpowered statistically. There appeared to be no statistical analysis provided at ASH perhaps for the same reason. Please share your thoughts. bp
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karagozoglu12345
Posts: 61
Joined: Wed Oct 03, 2018 12:48 am

Re: New FDA guidelines

Post by karagozoglu12345 » Fri Jan 04, 2019 12:05 am

I believe the use of control arm in the trial is going to work to our favor in talks with FDA.
Please see: ncbi.nlm.nih.gov
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biopearl123
Posts: 1670
Joined: Fri Jul 20, 2018 5:13 pm

Re: New FDA guidelines

Post by biopearl123 » Sun Jan 06, 2019 6:49 pm

Technically, this is a "comparator arm" not a control arm in the strict sense of treatment vs. no treatment but I do agree that the FDA should be able to use this information in a favorable manner. bp
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