Let’s focus on the main game for a moment.
There have now been 15 comments submitted for consideration by the ODAC committee on Thursday.
The latest is from a Dr Tom Shannon, definitely very supportive of MSB’s application.
Dr Shannon is “excited by the prospect of a new type of therapy targeting inflammation, without the side effects of steroids and NSAIDS or even chemotherapeutic / disease modifying agents”.
He says “I was concerned to see details today of advice that may restrict access … If safety and efficacy can be achieved, even with the issues of QA around cell lines, then surely those treatments are valid.”
Definitely worth a read.
https://beta.regulations.gov/document/FDA-2020-N-1539-0037
Herro.
FDA ODAC Meeting Material discussion analysis, page-215
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