A wonderful summation of the state of things

[biopearl123]

This is the opening paragraph of a paper by Chandhok and Sekeres in "Leukemia" Feb 15th which I can't copy here sums up the sorry state of affairs in the current treatment of LR/MDS and confirms the absence of data to support improved survival (with current treatment) and the dreadful dependence of patients on blood transfusions.

[kmall]

Ridiculous that the FDA didn't set priority review here. Hundreds, if not thousands of patients will needlessly die while they dragged this out an additional 10 months......what the hell does Fast Track Designation imply? -Kmall

[Ryan]

I think it’s a foregone conclusion that the reason for standard review is because Imet is a New Molecular Entity and thus a committee review was warranted.

[Hoosier Investor]

One could argue the FDA has pulled up the date of our ADCOM review. Dr. Scarlett previously indicated we should expect one a few weeks prior to the PDUFA date.

[kmall]

Ryan - understood, but the data is the data....it's superior to any other BAT, and they had 8+ months to review before making that decision. New molecular drugs have been approved in the past to serve an unmet need. It certainly appears to be a case of more than meets the eye in the approval hurdles this drug has been sidelined by. And let's not forget patients in the CT had a much higher transfusion burden than other drugs which cleared approval. I'm on the fence if it was necessarily "warranted." -Kmall