Monday, April 23, 2018 1:42:29 PM
I agree, those 3 things are most important. Out of curiosity, have you ever seen one come through requesting compassionate use for psoriasis for psoriasis?
After listening to the 3/17/16 fda patient-focused drug development conference for psoriasis, I was blown away by how much those with psoriasis go through- on many different levels. It was clear by the fda panelists comments during the conference, but particularly at the conclusion, that they were blown away as well.
If P2b data is good, I could easily see P being requested for use via compassionate use. Many of the patients who spoke of how many different medicines they've been prescribed over the years. Others spoke of their concern of health side effects in taking these drugs,and they are real concerns such as liver disease, diabetes, heart disease to name just a few, there were many others stated.
I've provided the link again in the event you hadn't listened(there is a link for the transcript of the session at the bottom) and may want to. It's long, I listed in sections as time allowed over a few days(5 hours total +-).
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm
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