SAP is a perfect candidate for accelerated approval in refractory MDS. SAP has repeated demonstrated itself to be "safe and active" in hematological cancers. MDS patients following HMA failure face a death sentence. SAP has shown to double survival in early results of this patient population. There is no better candidate than SAP for accelerated approval.
Refractory MDS would obviously be easier to get accelerated approval than the front line. This is why after initial results were released on SAP phase 2 in refractory MDS, there was a little "buzz" in the air about the "FDA registration pathway". Keep your undies on!!!
I have mentioned this point on several occasions. Your logic is correct. Longer results is something to wish for. FYI, MDS market is 6-7 times the size of AML. Virtually all patients relapse in MDS. So, the refractory MDS market is very lucrative. However, since SAPACITABINE addresses a unique spectrum of blasts, it may very well migrate to frontline MDS.