CEO Itescu needs to go, page-780

@dachopper
@techinvestor

The FDA’s allowance for real world evidence in supporting drug approval is examined in this 2019 article, which cited 8 articles

https://journals.sagepub.com/doi/full/10.1177/1932296819832661en

published by different people at the agency to explain what exactly it is:

The examples are essentially the study or “studies” referred to in the CC after the latest CRL and they need not be randomised or placebo controlled but the data would still be accepted by the FDA. I notice @Phaedrus posted about the topic as well. If you do an advanced search for MSB under the authorship of Phaedrus, you will find the post with a diagram produced by the FDA to explain RWE.

This is the second reason why the data request by the FDA as part of the latest CRL may in fact not be as onerous as it first looked (the first reason being that the company now understands a lot more about the MoA, CQA, product potency and the use of biomarkers to predict responders and target the success rate, as I explained in my preceding post). I think this is also why this latest data requirement is characterised as the last 10% of work that the company needs to do to get full approval.