Hi @chuckeOverdue, I believe. The corporation's more than kept...

Hi @chucke

Overdue, I believe.

The corporation's more than kept faith with the Administration's preferred processes since 2020.

While FDA dragged itself (lethargically) up to some semblance of a speed & competency adequate to deal with the cellular and gene therapy revolution, Mesoblast Ltd honoured its commitment to support USA (& I believe other) cliinicians' hippocratic obligations & professional requests for assistance. It did this despite COVID-19, the lure of unregulated stem cell clinical practices and the impact of resulting rigorous process delays on Mesoblast's own business model and financial situation. It avoided dispute resolution procedures, and the risk of an acrimonious relationship. IMO these things will stand Mesoblast Ltd in good stead for the short-term & longer term regulatory interactions in the USA in future.

I still believe Dr Wilson Bryan, Director of OTAT (CBER) was speaking an FDA truth when he said, in the FDA's Opening Remarks, on August 13, 2020:

" ... we very much appreciate the efforts of Mesoblast to undertake clinical studies and develop their products to address an unmet need. "

However, I feel the FDA has inexcusably failed to honour its own obligations and commitments - in Bryan's own words:

" Throughout our consideration of this BLA, it is critical that we remember that these are highly vulnerable patients. They are vulnerable because they have a life-threatening disease... And they're vulnerable because for the patients who are less than 12 years old, there is no FDA-approved therapy for steroid-refractory acute GVHD, so there is a substantial unmet medical need. It is critical that we make our regulatory decisions with these patients and their vulnerability in mind. . "

IMO, the ODAC members responded to that.

The subsequent abject failure to do that - that's all on the FDA's own administrators. And it has made something of a mockery of the feeble bureaucratic effort to address that vulnerability. So we had to wait till 2023 even to get published draft Guidances on Cell and Gene Therapies that addressed some of the points the FDA was incorporating in CRLs willy nilly.

Hopefully, we're on the same sheet of music now.

Cheers
GLTAH