You have far more than I do, but I believe your 50/50 to be substantially to low. With a SPA requiring a two month advantage over the control group, the trial has advanced nearly a quarter beyond when it was initially due to end. Many I've heard from believe the patients on the SOC simply will not live the nearly 2 to 3 months longer that they would need to for the data not to show a gain well over the 2 months needed to be achieved. Many don't believe the control will have a median survival of 6 months, if they're right, for the trial to end roughly now I figure the median for those on Perifosine is nearing a year. I'm not saying we're that much better, but for one months extension of the trial, if the control doesn't live longer, the drug group must live 2 months more as in this trial they're evenly divided. We're currently roughly 2 to 4 months beyond the originally estimated period, that should add 4 to 8 months to what the patients that get the drug get.
I believe if a company says a trial's estimated to complete in a quarter, they're guessing at the mid month of that quarter. If for instance the target month was October, I think they'd have said 3rd or 4th quarter, and for December they'd have said 4th or 1st quarter. If I'm correct, they're now 2 plus months beyond their original estimate, so if the control group's at 6 months, and it could be less, the Perifosine group which would need to be 8 months ought to be at 12, i.e. 4 months longer than expected for the trial running 2 months longer.
I'm guessing that Top Line Data will take at least a few weeks, and perhaps over a month, after the actual 360th event is established. Frankly if this were a big Pharma running the trial we'd not be told anything until the data could be discussed. I don't think that will be the case here, and because top line won't come immediately, bashers will attempt to create doubt. I don't know they'll be successful, but right now anticipation of results should be moving this stock. In that it hasn't I've got to believe investors are nervous, but at this price with the size of the pipeline and even better data expected from the MM trial, any further weakness shouldn't be that bad. Certainly there is always a downside, but the upside potential is so much greater here.
Frankly after IMGN has approval on T-DM1 and AEZS has approval on Perifosine, I believe both companies could have near equal market caps. IMGN would be priced higher as they have fewer outstanding shares, but they'd be much closer in share price than they are today. Should AEZS-108 approval be anticipated before IMGN has a drug in Pivotal Trials, it could pass IMGN's share price and if not then, certainly with the approval of AEZS-108. I still believe IMGN has one of the strongest pipelines I'm aware of, but AEZS's is amazing for such a low priced stock.
Gary |
