I really think it's too early to say what the potential is of the two newest adds to the pipeline. N901-DM1 on the other hand is IMGN's very oldest TAP technology, it may be approvable, but I can't help but believe better conjugates of N901 could be created and be far more effective.
I think it's far too early for AEZS to even consider a R/S. Just moving AEZS-130 toward approval ought to bring the price to the $1 range, certainly its approval will put it there. By the time this happens, we'll also know if it's effective for cancer cachexia. This could turn a niche drug into a far bigger product. The nice thing about this trial is that little doubt will exist as to if it works or not, an every day floor scale should be all that's needed to tell the tale. If patients who're losing weight uncontrollably stabilize their weight and start putting weight back on, it's working. I believe it's as simple as that. Currently there is no treatment for it, so approval shouldn't be difficult, and perhaps it could even come from a Registrational Phase II Trial, perhaps expanding on the current trial, but even if it goes to Phase III, with this the only know treatment, rapid enrollment and results ought to be easy.
Gary |