Thread by @VPrasadMDMPH

New paper out led by @mlythoe @vkprasadlab

We summarize comments received by FDA in response to their proposal that you don't need to receive standard of care to enroll in trials

We detailed the proposal first in NRCO...
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authors.elsevier.com/a/1eTQf7tJEDOI…

Here was that summary along with pitfalls

https://twitter.com/vkprasadlab/status/1438877919254695943?s=20

Now many have written to the FDA supportive of changes, which will allow easier paths to front line and large market share

It seems like it will come to pass

drug regulation will always favor the companies over the average person because a small motivated minority can always defeat a large and disinterested majority