I’m sure most readers recall the large number of public...

I’m sure most readers recall the large number of public submissions to the ODAC Committee, in the days leading up to the meeting.

https://beta.regulations.gov/document/FDA-2020-N-1539-0038

One of those was from a Dr Cass M. Phd., described as a ‘Biomedical and inflammatory disease researcher’.

Looking back on it, I am astounded at how on the money the Dr’s submission was! (and still relevant now)

Here’s a few excerpts: (the highlighting is mine)

“I strongly urge the FDA to approve remestemcel-l to treat SR aGVHD in paediatric patients 12 years and under, on the basis that it is safe, pure and has proven efficacy. I also suggest the FDA consider the biological/cellular nature of remestemcel-l and to use care when applying requirements that would normally be reserved for pharmaceutical compounds . . . . .

It would be an unrealistic expectation to request characterisation of the precise mechanism of action of a treatment that is multimodal in function and administered in its natural, unmodified form. Instead I urge the FDA to take into account the scientific consensus as it relates to the immunomodulatory function of the mesenchymal stem cell . . . . .

I am deeply concerned the FDA is considering an additional clinical trial because the patient population is vulnerable and small in number and it will only serve to generate further delays . . . . .

In addition, a request for a placebo controlled clinical trial to treat children for a disease with a high mortality is unethical . . . . .

A negative decision made by the FDA will likely have a material impact on the cellular therapy industry and hinder further innovations. Your decision is important and has far reaching implications well beyond the current BLA application . . . . .

Approval of the first allogenic cellular therapy by the FDA will signal to academics and industry partners that a commitment and dedication to producing new, innovative, safe and effective treatments is welcomed . . . . .

Currently cellular therapies do not receive the focus and attention that they should. Unfortunately, it is children similar to those in this study that pay the price.”

Clearly Dr Cass saw the writing on the wall that others (including me) didn't.

If there were public submissions to the Type A meeting, I wouldn’t change a word!

Usual bias. Keep the faith.
Herro