Replies to post #2445 on Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

What got me thinking along those lines is that Fast Track can use

nonclinical or clinical data demonstrate the potential to address unmet medical need

and this study is one that you should be doing early in the program. It could be that they recently realized that they needed to do it but the correlation with getting meeting notes from the FDA on BTD rejection and starting this study seems more than just coincidental. Anyhows, as you said, they'll be dotting their Is and crossing their Ts w this study.