Ann: Update on BLA for Graft Versus Host Disease, page-243

Long term supporter of the company and SI.
Posting for first time.
I want to believe there should be a good reason for FDA to do what they did.
Could it be- That once approved for one indication, and in the hospital shelves, FDA is worried, doctors would be tempted (for good reason) to use it (off-label) for COVID-ARDS?

This could have implications for not only - Use without full evidence, supply constraints for the indication approved, manufacturing capacity not ready, etc.

So this could be a way to buy time, while they get more evidence for COVID use, which is probably their number 1 worry at the moment.

If it is, I am still positive.
Just delays my personal plans a little bit.
Not that I was in a rush to sell.