The clinical trial indicated Reolysin great success in "shrinkage of tumor"
If so, can ONCY receive immediate FD approval and market the product or more tials are necessary ?
Preoperative usgae of Reolysin would stand alone as a financial success ?
Please a serious response
As far as I can tell, products that are used in conjuction with surgery have had a separate trial to demonstate that they are synergistic with surgery. Cetuximab can be administered in the early stages along side surgery. This was a separate trial then the EXTREME trial for first line relapsed.
I haven't reviewed the entire space. If oncologists feel that, in their experience, more tumor shrinkage prior to surgery generally translates to better outcomes, they could use REO without the official approval of the FDA.