Like many of you, I too was taken aback from the 'Tefferi et al' Letter to NEJM.
I have my own views about Tefferi and knew instantly about his YMI partnership, having listened to his presentations on their behalf at ASCO/ASH. I do not like this individual one bit.
Having said all that, I was flummoxed to see the following in their Letter " Treatment has so far been discontinued in 47 patients (92%). Rates of treatment discontinuation at 1, 2, and 3 years were 51%, 72%, and 89%, respectively. Reasons for treatment discontinuation included disease progression or loss or lack of response (40%) and toxicity with or without disease progression or lack of response (34%). "
Let's consider the fact that this is an early trial, optimmum dosage and titration strategy had not been established. Most of the patients were the worst ones possible etc. So, considering all that, how does one still get only 8% of the patients remaing after 3 years?
Let's say for arguments sake that that this is bad treatment regimen, biased or incompetent MD's, etc. We know that even from INCY at least 20% drop after Year1. What we don't know is drop rates in Year 2 and 3 and thereafter. Even if instead of 8%, we have 40% continuing after 3 years, that would wreck immense financial havoc on any INCY NPV model.
So, for me, what I really need to know is drop rate for whatever reason in Years 2-4.
Anyway, full disclosure. Based on the 3 different areas where this letter had taken a drug that had been perceived as relatively clean and murkied up the waters and raised clouds in 3 areas (financials, rebound effect and response rate), resulting in a very difficult situation for the FDA, I too sold all my holdings first thing early AM yesterday and kept my hedges that I already had prior to this Letter. |
