I’ve been trying to work out what is going on, and I don’t think...

I’ve been trying to work out what is going on, and I don’t think Lassman is acting on behalf of CDER. I’ll admit I’m wading in deep past my expertise, so happy to be corrected if I’m off track.

I tried to find similar documents in older meetings. I came across a couple of “comment” documents labelled with “Author(s): CDER”. The ones I found seemed to be just regular submissions (eg. https://beta.regulations.gov/document/FDA-2019-N-5552-0014). I think maybe “Author(s): CDER” just means that they are the government agency/department/etc that has uploaded the document. Our meeting is listed as Center: CDER, so could make sense they are responsible for the submitted docs.

If my interpretation is correct, that would leave us with the potential of Lassman acting on Mesoblast’s behalf, a competitor/objector or some other interested party. Lassman seems to have some seriously specialised experience, and would seem to be the exact sort of person to hire to help us through final steps in FDA approval (especially if trying to set up optimal chances for label extensions/subsequent approvals).