manufacturing of msb cells, page-4

not talking about rejection dv - that's different. Thats an immune response.
i'm talking about 1. the fact that msb only get 500-1000 patients per donor (and there are millions of heart filure patients) 2. that every donor is differnt and 3 that they'll need to show that product madefrom each donor is as clinically effective as the original ones.
FDA call it "substantially biologically equivalent (i've got a relly in the business!).
Southern Cross say about 24m heart failure ptients globally.
Say msb get 5% = 1.2m patients. 1000 doses/donor = 1200 donors!Just for cardiac.Big number esp if they need to show that product made from each is "substantially biologically equivalent"
So thanks for your response but its not the question I asked.
And I do read up. But i think for meself as well.