Mr. Chairman

[biopearl123]

I thought Dr. Madan was fair and even handed in the way he ran the ODAC meeting, even charming. Interestingly, he readily admitted to not being a heme/onc doc but a solid tumor specialist and that he would rely heavily from the input from his heme onc colleagues. But seemingly he did not. In so stating that he felt the risks outweighed the benefits, his vote flew in the face of what he heard (and we heard), from the heme/onc specialists not only on the committee but also those who gave outside comments from both with in the company and without. (Everyone should go to Italy, Dr. Santini had no extra heme complications!) Every heme onc doc felt the side effects particularly the cytopenias could be managed and that this was part of everyday life in the management of treating these diseases. Dr. Madan however discounted the competence of his colleagues to do so. Now that is a mystery. The powerful patient comments and their pleas to be heard were indeed heard by everyone on the panel expect the two who have no first hand knowledge in the treatment of these diseases. That is a mystery. Mr. Chairman, perhaps once you have a chance to sleep on all of this you will facilitate approval so patients can get this drug. Did I hear correctly that adverse effects from transfusions (fluid overload, transfusion reactions due to antibody development, hours of travel and difficulties in finding good matches etc) were split out when evaluating drug side effects so as to just look at adverse reactions from Imetelstat alone? The problems related to that approach spreal for themselves. The study met its primary and key secondary end points. The finding from PII were reproduced in PIII (not usual!). QOL has to be evaluated through the lens of fewer or no transfusions. Patients going through therapy for years now. Mr. Chairman, I ask you. Charming and disarming but not listening even when he said he would. There is still time.

[biopearl123]

Of the 12-2vote, he almost said overwhelming but he stopped himself—but it was.

[jayfish101]

Excellent points, Biopearl!

[biopearl123]

Pretty sure one of the docs (?Dr. Savona) said about 30% of the Lus patients couldn’t get past the first dose because of fatigue. Did anyone else hear that?