The FDA is highly unlikely to deny an application if there are...

The FDA is highly unlikely to deny an application if there are no adverse events and if there is a real benefit to the patient. I think Recell has, at this time, passed both limbs of that test. The BARDA money and the compassionate use allowance is seemingly adding more (positive) data to help AVH get the regulator to approve the product. If the approval comes through then the next big test will be "is the product going to get reimbursement". That, of course, is another very important matter. GLTA