I certainly was wrong about purchasing Jan 14 calls, but I also did pick up a few shares at near the low, so long term I believe I'll be well ahead. I believe that we had two things against us in the last several months, but long term they could be in our favor.
One thing was certainly the interim report of the Phase 2 Trials which indicated less than anticipated benefits in using IMGN853 with other drugs. I still believe that in the end certain combinations will be found that make it work better than it does as a monotherapy, but it will be awhile before that's known, and it might be with drugs that haven't yet been tested with it.
The big thing is completion of the Phase 3 Trial. I had believed that we'd have top line results by now. The fact that we don't makes me believe that patients in the trial are living longer than originally anticipated, which should be good, but I have been wrong about it being good in some other drugs as the control was found to be living longer too. I'm not a big believer in using control groups, I believe that trial goals should be set based on current information at the time a trial is initiated, and all who enter the trial should be assured they're getting the experimental drug. I believe that many who enter trials where controls are used who suspect they're in the control arm will seek out additional treatment, which often does help them to live longer.
I'm a patient at City of Hope, and while I'm in full remission, it's been amazing to hear the story of some patients who've been given up for dead by others, in some cases decades ago. City of Hope is willing to experiment with people in ways that few oncologists would, including in some cases making individualized drugs to help them. I was fortunate, somewhat conventional treatment along with stem cells has me in remission, but others I met clearly had treatment that went well beyond documented approved treatment. With the new right to try, as well as the older compassionate use provisions, I suspect that COH has often used drugs in ways they were not documented to use. My own chemo protocols were greatly shortened in preparation for stem cells after COH took over my treatment.
I don't know when we'll get top line results, but when we do, I suspect we'll see new highs as long as they suggest approval is reasonably certain in the future. If there is a serious question, but the company's proceeding toward filing a BLA, the stock should rally some, but perhaps not to new highs until we have an approval from the FDA. Of course a trial failure would send the stock to new lows that may not have been seen for decades in spite of positive data from newer drugs in early stage trials.
Gary |
