There are many flaws to the bear thesis.
First, they neglect the lack of serious side effects. All of the current therapies have serious side effects and none are a cure. The response rates on current treatments is relatively low. Even if A7 has a similar low response rate (and it will probably be higher) cancer patients will first try the therapy with no side effects over those with serious side effects. Moreover, even for patients that use the current therapies when they fail (and almost all do) they will eventually use A7. So using a 5% 10% expectation of market share is ridiculous.
Second, it is highly unlikely that the control group on DTIC will achieve median survival of 18 months. The trial is 63% stage 4 and 37% stage 3 unresectable. Never in dozens of trials have DTIC patients approached median of 18 months. Likely median survival for the control group is in the 13-16 month area. The A7 arm should be able to beat such numbers significantly.
Third, even at its relatively small size the trial is large enough for stat sig survival. If the control arm median survival is 14 months A7 only needs to exceed 18 months to be stat sig. If the control arm median survival is 16 months, the A7 arm would be stat sig at 21 months. Even if the control arm somehow reached 18 months, the A7 arm need only exceed 23 months to be stat sig. Given the delays, we should easily see the A7 arm exceed these levels. Remember in phase 2, chemo naive patients such as those in phase 3, had a median survival of 22.5 months and that is with 61% having received only 1 or less courses of A7. In phase 3 all patients got at least 2 courses.
Fourth, the analyst have not comprehended that the future of melanoma therapy is going to be combinations of drugs either concurrently or consecutively. Under such combo therapy a drug that has virtually no side effects and provides a target for t-cells will be critical. As of now, A7 looks to be the only drug that fulfills that need.
Great summary of the more constant known's. I appreciate the consistency of your post over the past years. Speculation in predicting both survival and response rates is precarious since these are non linear and chaotic events in a small trial. Therefore routine statistical back calculations do not apply. I appreciate your steadfast conviction not to overextend the predictive power of intuition. However, I have grown both weary of the length of the trial yet have this phrenetic excitement that information will be released during this quarterly report. It is highly unlikely they will release the results then. Since it is a tradable event which is likely to be released as a early am PR. From a purely academic point of view I really want to see the response data. From the response data, A-7 will shine as stalwart mechanism to treat carcinoma(provided it is convincing). I was convinced when the showed those demo photo's 2yrs ago that showed the amelanosis of the skin surrounding the lesion and the ct scan of chest with reduced as well disappearance of metastatic dz. In my book A-7 is not snake oil but certainly need refinement in pt selection and dosing regimens. All of which will come in time. THX. The booger
I subscribe to your first and fourth points, because they are accurate and proven, even without the data lock results. The combo-therapy advantages of a treatment that is virtually free of adverse reactions is obvious. A7 could be almost as widely used as adjuvents, in a somewhat similar "booster" role.