Getting respect in the investment community has been an issue with this company ever since OCT 2011 when they announced the failure to get a SPA for Comet 2. Management had built up the expectation that agreement was near and that a pain/bone resolution endpoint was a shortcut to a quick approval. The street still has not forgiven or gotten past that seminal moment. Meanwhile the medical community looks on Comet with great interest. Originally there was skepticism about the whether the bone met resolution issue was a imagining artifact or if it represented genuine disease regression. Then came the ASCO 2011 realization that Comet is a toxic drug. This was not so much a surprise to the medical community, but the Street still has trouble putting toxicity in context with indication. Toxicity that makes a diet or diabetes drug unapprovable is considered managable and acceptable in refractory cancer indications. The MTC approval situation is a headshaker. Speculative money poured into the stock and the expectations were absurd. When the 1000 patient indication size was mentioned in the CC, the balloon deflated...again. The clinical results keep coming in and the professional biotech analysts are getting on board, but there is a "show me the money" mentality now that will not go away. I had expected a a pop in price after the MTC approval with a retracement that would finally put in a rock hard bottom and signal a change in expectation. I was obviously wrong.
Still, my opinion of the drug and the stock has not changed. RCC and HCC pivotal trials will be announced. Phase 2 trial presentations will continue. EXAM survival data will come out in 2013. And perhaps the Thyroid committee will give its blessing to DTC off label use. Even if that happens, do not expect great things. Comet would be one of 4 off label drugs for the same indicaton and oncologists are slow to incorporate even FDA approved drugs into their repertoir, let alone off label compendia listings. I had expected to be out of EXEL by now, but I can wait a while longer. I root for the Atlanta Falcons and despite being 11-1, I watch Howie, Terry, Jimmy, and Curt predict their demise week after week. Why should this be any different?